Devices › Orthopedic manual surgical instrument
Device brand name · Misc ortho surgical instr
Standard Insertion Handle: medical device reports filed with FDA
225 reports name it, 2011–2023. Manufacturer given most often on reports: Synthes Hagendorf. Product code LXH.
- 225
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 81.3%
- classified as malfunction
- 90.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 225 reports that name the brand "Standard Insertion Handle" (misc ortho surgical instr), received between January 2011 and November 2023; the manufacturer given most often on reports is Synthes Hagendorf. 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 malfunction (81.3%) and injury (18.7%); across all orthopedic manual surgical instrument reports (product code LXH) death is recorded in 0.1% and malfunction in 90.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (32%), failure to align (17.3%) and device-device incompatibility (12.4%). The patient problems coded most often are no patient involvement, sedation and device embedded in tissue or plaque. 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 81,663 reports carrying product code LXH. 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 | 72 | 32% | 43.5% |
| Failure to align | 39 | 17.3% | 0.7% |
| Device-device incompatibility | 28 | 12.4% | 7.5% |
| Fitting problem | 19 | 8.4% | 0.7% |
| Mechanical jam | 14 | 6.2% | 2.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 11 | 4.9% | 2% |
| Bent | 9 | 4% | 0.9% |
| Material fragmentation | 8 | 3.6% | 1.4% |
| Component missing | 6 | 2.7% | 1% |
| Detachment of device component | 5 | 2.2% | 2.7% |
| Positioning problem | 5 | 2.2% | 0.3% |
| Component falling | 2 | 0.9% | 0.5% |
| Deformation due to compressive stress | 2 | 0.9% | 0.1% |
| Device slipped | 2 | 0.9% | 0.8% |
| Difficult to position | 2 | 0.9% | 0.1% |
| Failure to advance | 2 | 0.9% | 0.4% |
| Sticking | 2 | 0.9% | 0.8% |
| Contamination /decontamination problem | 1 | 0.4% | 0.7% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.4% | 0.1% |
| Device or device fragments location unknown | 1 | 0.4% | 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 | 30 | 13.3% |
| Sedationdrowsiness from a medicine | 17 | 7.6% |
| Device embedded in tissue or plaque | 4 | 1.8% |
| Failure of implant | 2 | 0.9% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.9% |
| Bone fracture(s) | 1 | 0.4% |
| Nonunion/delayed-union bone fracture | 1 | 0.4% |
| Not applicable | 1 | 0.4% |
| Painpain, site not specified | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Standard Insertion Handle | Product code LXH | All MAUDE reports |
|---|---|---|---|
| Reports | 225 | 81,663 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 18.7% | 9.2% | 36.2% |
| Classified as malfunction | 81.3% | 90.1% | 62.3% |
| Filed by the manufacturer | 100% | 98.6% | 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 LXH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Excel T-Handle | 2,368 | 150 | 0% |
| Driving Cap/Threaded | 1,181 | 58 | 0% |
| Orthopedic Manual Surgical Instrument | 1,143 | 0 | 0.2% |
| Manual Orthopedic Surgical Instrument | 1,693 | 0 | 0.1% |
| METRx System | 1,679 | 267 | 0.1% |
| Glenosphere Inserter Tip | 812 | 175 | 0% |
| Baseplate Inserter Rod | 561 | 105 | 0% |
| 1.5mm Hex Driver Tip, Locking Groove | 580 | 332 | 0% |
| R3 Straight Shell Impactor | 565 | 21 | 0% |
| Driving Cap | 497 | 65 | 0% |
| 5mm Hex Flexible Screwdriver | 498 | 60 | 0.2% |
| Attune Mod Post Saw Cap Sz 6-8 | 486 | 41 | 0% |
| Exactech | 576 | 0 | 0% |
| Attune Femoral Impactor | 3,328 | 121 | 0% |
| Metrx | 415 | 3 | 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 Standard Insertion Handle reports
How many FDA reports name Standard Insertion Handle?
225 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 (81.3%) and injury (18.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (32%), failure to align (17.3%), device-device incompatibility (12.4%), fitting problem (8.4%) and mechanical jam (6.2%). 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 Standard Insertion 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.