Devices › Drill, surgical, ent (electric or pneumatic) including handpiece
Device brand name · Drill surgical ent electric or pneumatic including handpiece
Anspach Xmax: medical device reports filed with FDA
262 reports name it, 2014–2014. Manufacturer given most often on reports: Depuy Synthes Power Tools. Product code ERL.
- 262
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 100%
- classified as malfunction
- 98.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
262 medical device reports received by FDA name the brand "Anspach Xmax" (drill surgical ent electric or pneumatic including handpiece); the manufacturer given most often on reports is Depuy Synthes Power Tools; received from September 2014 to October 2014. 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 (100%); across all drill, surgical, ent (electric or pneumatic) including handpiece reports (product code ERL) death is recorded in 0% and malfunction in 98.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operates differently than expected (20.6%), break (19.1%) and device inoperable (12.6%). 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
No report naming Anspach Xmax was received in the five years to August 2026; the latest was received in October 2014.
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 29,931 reports carrying product code ERL. 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 operates differently than expectedthe device behaved unexpectedly | 54 | 20.6% | 3% |
| Breakthe device broke | 50 | 19.1% | 5.2% |
| Device inoperablethe device could not be used | 33 | 12.6% | 1.5% |
| Naturally worn | 26 | 9.9% | 0.5% |
| Overheating of device | 26 | 9.9% | 43.4% |
| Defective devicethe device was defective | 19 | 7.3% | 0.2% |
| Noise, audible | 19 | 7.3% | 2.9% |
| Defective component | 15 | 5.7% | 0.2% |
| Leak/splashthe device leaked | 13 | 5% | 2% |
| Hole in material | 11 | 4.2% | 1.5% |
| Power problem | 9 | 3.4% | 0.5% |
| Loose or intermittent connection | 8 | 3.1% | 0.2% |
| Partial blockage | 8 | 3.1% | 0.1% |
| Air leak | 6 | 2.3% | 0.7% |
| Component missing | 6 | 2.3% | 0.2% |
| Disconnection | 6 | 2.3% | 0.1% |
| Cut in material | 5 | 1.9% | 0.3% |
| Loss of powerthe device lost power | 5 | 1.9% | 0.3% |
| Output below specifications | 4 | 1.5% | 2.2% |
| Temperature problem | 4 | 1.5% | 2.5% |
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.
In context
| Measure | Anspach Xmax | Product code ERL | All MAUDE reports |
|---|---|---|---|
| Reports | 262 | 29,931 | 26,136,888 |
| Share of that pool | — | 0.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 0.9% | 36.2% |
| Classified as malfunction | 100% | 98.9% | 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 ERL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Xmax Motor | 4,447 | 0 | 0% |
| Remb Electric Sagittal Saw | 1,693 | 4 | 0% |
| Core Impaction Drill | 3,913 | 0 | 0% |
| S2 Drill | 844 | 79 | 0% |
| Motor Assembly Xmax | 893 | 14 | 0% |
| Ipc Handpiece - Xps Straightshot M5 | 711 | 124 | 0% |
| Remb Electric Micro Drill | 660 | 9 | 0% |
| Xps Handpiece - Visao | 649 | 12 | 0% |
| Ipc Handpiece - Xps Straightshot M4 | 607 | 45 | 0% |
| Pi Drive Plus Motor | 564 | 0 | 0% |
| Micro Sagittal Saw | 1,395 | 0 | 0% |
| Core Universal Driver | 679 | 0 | 0% |
| ENT Mr8 | 622 | 538 | 0% |
| Pi Drive Motor | 477 | 0 | 0% |
| Core Sumex Drill | 522 | 0 | 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 Anspach Xmax reports
How many FDA reports name Anspach Xmax?
262 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 operates differently than expected (20.6%), break (19.1%), device inoperable (12.6%), naturally worn (9.9%) and overheating of device (9.9%). 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 Anspach Xmax 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.