Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment: medical device reports filed with FDA

50,440 reports carry this product code, 1995–2026; 30 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

50,440
reports with this product code: 0.2% of all MAUDE reports; 2,410
reports, 12 months to August 2026: 3,249 in the 12 months before; 97.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code HWE is FDA's classification for "Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment" (general, Plastic Surgery panel), a class 1 device. 50,440 medical device reports carry this product code, 0.2% of the MAUDE database, from March 1995 to August 2026.

2,410 reports arrived in the 12 months to August 2026, down 26% from 3,249 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 (97.5%), injury (2.3%) and other (0.1%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Small Battery Drive	2,384	0	0%	99.7%
Colibri	1,367	0	0%	100%
Electric Pen Drive 60 000 Rpm	1,285	94	0%	99.1%
Sagittal Saw Attachment	1,170	64	0%	99.3%
Smartlife Large Aspetic Housing	1,132	2	0%	99.9%
Sagittal Saw Attachment Long For Trs	1,029	90	0%	99.5%
Quick Coupling For K-Wires	737	28	0%	99.2%
Epd 60000 Rpm	728	0	0%	99.2%
Air Oscillator	651	0	0%	100%
Chuck With Key/Drill Speed For Trs	640	94	0%	100%
Small Battery Drive Colibri	632	0	0%	99.5%
Modular Calcar Planer Sml	445	30	0%	97.1%
Sagittal Saw Attachment For Trs	424	77	0%	99.5%
System 6 Sagittal Saw	423	0	0%	99.1%
Unium Modular Handpiece	403	137	0%	100%
Modified Hudson Adapter	349	0	0%	99.5%
Ao Reaming Attachment For Trs	333	38	0%	100%
Oscill-Saw-Attachm F/532 001 532 010 532	325	0	0%	99.4%
Radiolucent-Drive	300	0	0%	97.1%
Hand Piece For Battery Powered Driver	293	66	0%	99.5%
Handle Battery Powered Driver	267	63	0%	100%
Oscill-Saw	260	0	0%	99.6%
System 6 Aseptic Housing Assy	237	0	0%	99.6%
System 7 Dual Trigger Rotary	228	0	0%	99.1%
Reciprocating Saw Attachment For Trs	221	35	0%	99.6%
Smartlife Small Asptc Housing	201	0	0%	100%
S-Rom Adaptor Hudson To Zimmer	200	6	0%	99.6%
Smartlife Large Asptc Housing	195	0	0%	99%
2 5mm Drill Bit/Qc/Gold/110mm	193	14	0%	74.1%
Sagitt Saw-Attachm Long W/T-Handle F/Trs	183	0	0%	100%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Synthes	13,603	27%
Depuy Synthes Power Tools	9,209	18.3%
Depuy Synthes Products	7,346	14.6%
Stryker Instruments-Kalamazoo	5,007	9.9%
Synthes Oberdorf	4,823	9.6%
Stryker Instruments-A Division Of Stryker	2,325	4.6%
Arthrex	859	1.7%
Conmed Linvatec	344	0.7%
Stryker Instruments Kalamazoo	300	0.6%
Depuy Ireland - 9616671	225	0.4%
Stryker	191	0.4%
Smith & Nephew	184	0.4%
Synthes USA	179	0.4%
Stryker Ireland	171	0.3%
Linvatec	154	0.3%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%7

Injury2.3%1,161

Malfunction97.5%49,199

Other0.1%57

Not given0%16

Who filed

Manufacturer report99.3%50,100

Voluntary report0.3%134

User facility report0%0

Distributor report0%14

Not given0.4%192

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Mechanical jam	6,597	13.1%
Physical resistance/sticking	5,129	10.2%
Breakthe device broke	4,126	8.2%
Complete loss of power	3,792	7.5%
Device inoperablethe device could not be used	3,449	6.8%
Unintended system motionthe device moved when it should not have	3,177	6.3%
Noise, audible	3,073	6.1%
Device operates differently than expectedthe device behaved unexpectedly	2,986	5.9%
Output below specifications	2,604	5.2%
Fracturea broken bone	2,226	4.4%
Fail-safe problem	2,184	4.3%
Overheating of device	2,114	4.2%
Excessive heating	1,745	3.5%
Detachment of device or device componentpart of the device came off	1,480	2.9%
Mechanical problema mechanical problem	1,164	2.3%
Partial blockage	1,021	2%
Disassembly	866	1.7%
Intermittent loss of power	756	1.5%
Sticking	747	1.5%
Failure to cut	727	1.4%

Questions about instrument, surgical, orthopedic, ac-powered motor and accessory/attachment reports

What is product code HWE?

FDA's classification code for "Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment", class 1, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

50,440 reports through August 2026, 2,410 of them in the latest 12 months.

Which brands appear most often?

Small Battery Drive (2,384), Colibri (1,367), Electric Pen Drive 60 000 Rpm (1,285), Sagittal Saw Attachment (1,170) and Smartlife Large Aspetic Housing (1,132). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.