Device brand name · Hip instruments handles
Summit Universal Broach Handle: medical device reports filed with FDA
341 reports name it, 2014–2025. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code HTQ.
- 341
- device reports naming the brand
- 0% of all MAUDE reports · about 28 a year
- 0
- reports, 12 months to August 2026
- 23 in the 12 months before
- 100%
- classified as malfunction
- 94.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 341 reports that name the brand "Summit Universal Broach Handle" (hip instruments handles), received between March 2014 and August 2025; the manufacturer given most often on reports is Depuy Orthopaedics US. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 23 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 (100%); across all broach reports (product code HTQ) death is recorded in 0% and malfunction in 94.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device-device incompatibility (40.8%), unintended movement (22.9%) and break (19.1%). The patient problems coded most often are not applicable and no patient involvement. 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 4,703 reports carrying product code HTQ. 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 |
|---|---|---|---|
| Device-device incompatibility | 139 | 40.8% | 34.9% |
| Unintended movement | 78 | 22.9% | 7.8% |
| Breakthe device broke | 65 | 19.1% | 25.7% |
| Loose or intermittent connection | 22 | 6.5% | 2.8% |
| Naturally worn | 11 | 3.2% | 4.9% |
| Structural problem | 11 | 3.2% | 2% |
| Scratched material | 10 | 2.9% | 5.1% |
| Connection problema connection problem | 7 | 2.1% | 1.8% |
| Material twisted/bent | 7 | 2.1% | 2.2% |
| Crackthe device cracked | 5 | 1.5% | 0.6% |
| Material deformation | 5 | 1.5% | 5.7% |
| Detachment of device or device componentpart of the device came off | 4 | 1.2% | 0.3% |
| Device slipped | 4 | 1.2% | 0.8% |
| Insufficient device problem information | 3 | 0.9% | 0.5% |
| Contamination /decontamination problem | 2 | 0.6% | 0.8% |
| Corrodedthe device corroded | 2 | 0.6% | 0.1% |
| Difficult to open or close | 2 | 0.6% | 0.4% |
| Material integrity problema problem with the device material | 2 | 0.6% | 0.9% |
| Positioning problem | 2 | 0.6% | 0.1% |
| Disassembly | 1 | 0.3% | 0% |
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 |
|---|---|---|
| Not applicable | 2 | 0.6% |
| No patient involvement | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Summit Universal Broach Handle | Product code HTQ | All MAUDE reports |
|---|---|---|---|
| Reports | 341 | 4,703 | 26,136,888 |
| Share of that pool | — | 7.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 5.1% | 36.2% |
| Classified as malfunction | 100% | 94.7% | 62.3% |
| Filed by the manufacturer | 100% | 99.5% | 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 HTQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Extra Curved Broach Handle | 382 | 0 | 0% |
| Corail2 Anterior Broach Handle | 312 | 0 | 0% |
| Corail Broach Handle | 263 | 1 | 0% |
| Actis Broach Sz 5 | 235 | 15 | 0% |
| Corail2 Straight Broach Handle | 204 | 0 | 0% |
| Actis Broach Sz 6 | 191 | 27 | 0% |
| Actis Broach Sz 4 | 167 | 8 | 0% |
| Actis Broach Sz 7 | 156 | 12 | 0% |
| Actis | 217 | 214 | 0% |
| Dlt Ts Cer Hd 12/14 32mm +1 | 157 | 2 | 0% |
| UNK Handle | 227 | 50 | 0% |
| Quickset Ace Grater Head 56mm | 898 | 12 | 0% |
| Quickset Ace Grater Head 49mm | 1,213 | 13 | 0% |
| Quickset Ace Grater Head 50mm | 954 | 10 | 0% |
| Quickset Ace Grater Head 51mm | 1,245 | 11 | 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 Summit Universal Broach Handle reports
How many FDA reports name Summit Universal Broach Handle?
341 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device-device incompatibility (40.8%), unintended movement (22.9%), break (19.1%), loose or intermittent connection (6.5%) and naturally worn (3.2%). 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 Summit Universal Broach Handle 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.