Device brand name · Reamer
Drive Shaft-Minimum 520mm Length-For Use With Ria: medical device reports filed with FDA
413 reports name it, 2006–2023. Manufacturer given most often on reports: Synthes Monument. Product code HTO.
- 413
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 88.1%
- classified as malfunction
- 95.7% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
413 medical device reports received by FDA name the brand "Drive Shaft-Minimum 520mm Length-For Use With Ria" (reamer); the manufacturer given most often on reports is Synthes Monument; received from April 2006 to April 2023. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (88.1%), injury (11.6%) and death (0.2%); across all reamer reports (product code HTO) death is recorded in 0% and malfunction in 95.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (85.5%), material fragmentation (7.7%) and detachment of device component (3.1%). The patient problems coded most often are no patient involvement, device embedded in tissue or plaque and foreign body in patient. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 29,443 reports carrying product code HTO. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 353 | 85.5% | 13.6% |
| Material fragmentation | 32 | 7.7% | 0.6% |
| Detachment of device component | 13 | 3.1% | 0.7% |
| Entrapment of device | 8 | 1.9% | 1.5% |
| Detachment of device or device componentpart of the device came off | 7 | 1.7% | 0.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 1.5% | 0.3% |
| Component missing | 5 | 1.2% | 0.2% |
| Mechanical jam | 5 | 1.2% | 0.4% |
| Component falling | 4 | 1% | 0.2% |
| Bent | 3 | 0.7% | 0.1% |
| Cut in material | 2 | 0.5% | 0% |
| Device or device fragments location unknown | 2 | 0.5% | 0% |
| Failure to adhere or bond | 2 | 0.5% | 0% |
| Material integrity problema problem with the device material | 2 | 0.5% | 0.2% |
| Device packaging compromised | 1 | 0.2% | 0% |
| Device-device incompatibility | 1 | 0.2% | 3.2% |
| Disconnection | 1 | 0.2% | 0% |
| Fitting problem | 1 | 0.2% | 0.1% |
| Fracturea broken bone | 1 | 0.2% | 1% |
| Loose or intermittent connection | 1 | 0.2% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 99 | 24% |
| Device embedded in tissue or plaque | 13 | 3.1% |
| Foreign body in patientpart of a device left in the patient | 10 | 2.4% |
| Sedationdrowsiness from a medicine | 3 | 0.7% |
| Nonunion/delayed-union bone fracture | 2 | 0.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.2% |
| Deaththe patient died; cause not stated by this term | 1 | 0.2% |
| Failure of implant | 1 | 0.2% |
| Impaired healingslow healing | 1 | 0.2% |
| Inadequate osseointegration | 1 | 0.2% |
| Injurya physical injury | 1 | 0.2% |
| Swellingswelling | 1 | 0.2% |
| Tissue damage | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Drive Shaft-Minimum 520mm Length-For Use With Ria | Product code HTO | All MAUDE reports |
|---|---|---|---|
| Reports | 413 | 29,443 | 26,136,888 |
| Share of that pool | — | 1.4% | 0% |
| Classified as death, per 1,000 reports | 2 | 0 | 9 |
| Classified as injury | 11.6% | 4.1% | 36.2% |
| Classified as malfunction | 88.1% | 95.7% | 62.3% |
| Filed by the manufacturer | 100% | 99.2% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code HTO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Quickset Ace Grater Head 51mm | 1,245 | 11 | 0% |
| Quickset Ace Grater Head 49mm | 1,213 | 13 | 0% |
| Quickset Ace Grater Head 53mm | 1,197 | 10 | 0% |
| Quickset Ace Grater Head 47mm | 1,170 | 13 | 0% |
| Quickset Ace Grater Head 55mm | 1,157 | 10 | 0% |
| Quickset Ace Grater Head 57mm | 1,098 | 9 | 0% |
| Quickset Ace Grater Head 52mm | 982 | 10 | 0% |
| Quickset Ace Grater Head 50mm | 954 | 10 | 0% |
| Quickset Ace Grater Head 48mm | 951 | 9 | 0% |
| Quickset Ace Grater Head 54mm | 935 | 10 | 0% |
| Quickset Ace Grater Head 56mm | 898 | 12 | 0% |
| Quickset Ace Grater Head 45mm | 1,024 | 13 | 0% |
| Unk Reamer | 833 | 71 | 0% |
| Quickset Ace Grater Head 46mm | 836 | 9 | 0% |
| Quickset Ace Grater Head 59mm | 739 | 9 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Drive Shaft-Minimum 520mm Length-For Use With Ria reports
How many FDA reports name Drive Shaft-Minimum 520mm Length-For Use With Ria?
413 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (88.1%), injury (11.6%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (85.5%), material fragmentation (7.7%), detachment of device component (3.1%), entrapment of device (1.9%) and detachment of device or device component (1.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Drive Shaft-Minimum 520mm Length-For Use With Ria was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.