Devices › Plate, fixation, bone
Device brand name · Drill bit
Synthes: medical device reports filed with FDA
470 reports name it, 1994–2023. Manufacturer given most often on reports: Synthes. Product code HRS.
- 470
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 36.4%
- classified as malfunction
- 22.8% across the product code
- 0.6%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 470 reports that name the brand "Synthes" (drill bit), received between January 1994 and October 2023; the manufacturer given most often on reports is Synthes. Spellings of one product vary from report to report.
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 injury (57%), malfunction (36.4%) and other (4.5%); across all plate, fixation, bone reports (product code HRS) death is recorded in 0.2% and malfunction in 22.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (42.8%), explanted (33.8%) and fracture (16.2%). The patient problems coded most often are surgical procedure, surgical procedure, repeated and pain. 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 38,974 reports carrying product code HRS. 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 | 201 | 42.8% | 24.2% |
| Explanted | 159 | 33.8% | 3.8% |
| Fracturea broken bone | 76 | 16.2% | 7.5% |
| Replace | 67 | 14.3% | 1.4% |
| Device, or device fragments remain in patient | 52 | 11.1% | 0.1% |
| Device issuea problem with the device | 39 | 8.3% | 0.2% |
| Implant, removal of | 37 | 7.9% | 0.6% |
| Tip breakage | 23 | 4.9% | 0% |
| Difficult to removethe device was hard to remove | 19 | 4% | 0.9% |
| Difficult to insertthe device was hard to insert | 14 | 3% | 0.6% |
| Loose | 14 | 3% | 0.2% |
| Component(s), broken | 12 | 2.6% | 0.4% |
| Detachment of device component | 12 | 2.6% | 0.9% |
| Device, removal of (non-implant) | 11 | 2.3% | 0.1% |
| Bent | 10 | 2.1% | 0.8% |
| Crackthe device cracked | 8 | 1.7% | 0.6% |
| Device remains implanted | 6 | 1.3% | 0.3% |
| Migration or expulsion of device | 5 | 1.1% | 2.3% |
| Wire(s), breakage of | 5 | 1.1% | 0% |
| Collapse | 3 | 0.6% | 0.1% |
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 |
|---|---|---|
| Surgical procedure | 118 | 25.1% |
| Surgical procedure, repeated | 81 | 17.2% |
| Painpain, site not specified | 79 | 16.8% |
| Therapy/non-surgical treatment, additional | 59 | 12.6% |
| Nonresorbable materials, unretrieved in body | 56 | 11.9% |
| Hospitalization required | 53 | 11.3% |
| Failure of implant | 39 | 8.3% |
| Foreign body, removal of | 23 | 4.9% |
| Other (for use when an appropriate patient code cannot be identified) | 20 | 4.3% |
| Bone fracture(s) | 18 | 3.8% |
| Device embedded in tissue or plaque | 14 | 3% |
| Neck painneck pain | 13 | 2.8% |
| Device induced | 10 | 2.1% |
| Disability | 9 | 1.9% |
| Hip fracturea broken hip | 6 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Synthes | Product code HRS | All MAUDE reports |
|---|---|---|---|
| Reports | 470 | 38,974 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 6 | 2 | 9 |
| Classified as injury | 57% | 75.8% | 36.2% |
| Classified as malfunction | 36.4% | 22.8% | 62.3% |
| Filed by the manufacturer | 0.9% | 97.7% | 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 HRS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| UNK - Constructs: Plate/Screws | 850 | 9 | 0% |
| Unk - Plates | 494 | 0 | 0% |
| Level One Thoracic | 265 | 7 | 0% |
| Unk - Plates Trauma | 254 | 34 | 0% |
| Unk - Plates Spine | 178 | 0 | 0% |
| Ni | 32,939 | 1,587 | 1.8% |
| Level One Cmf | 546 | 32 | 0% |
| Unknown Screw | 1,222 | 156 | 0% |
| Baby Gorilla/Gorilla Plating System | 174 | 8 | 0% |
| Unknown Osteosynthesis Product | 198 | 0 | 0% |
| 1.5mm Hex Driver Tip, Locking Groove | 580 | 332 | 0% |
| Unk Screw | 195 | 63 | 0% |
| Unknown_Fro_Product | 192 | 7 | 0% |
| 3 5mm Cortex Screw Self-Tapping 14mm | 154 | 0 | 0% |
| ATLANTIS Anterior Cervical Plate System | 565 | 18 | 1.6% |
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 Synthes reports
How many FDA reports name Synthes?
470 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?
injury (57%), malfunction (36.4%) and other (4.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (42.8%), explanted (33.8%), fracture (16.2%), replace (14.3%) and device, or device fragments remain in patient (11.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (41.9%), manufacturer reports (0.9%) and distributor reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Synthes 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.