Saw, powered, and accessories: medical device reports filed with FDA

9,977 reports carry this product code, 1992–2026; 16 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.

9,977
reports with this product code: 0% of all MAUDE reports; 484
reports, 12 months to August 2026: 477 in the 12 months before; 95.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code HAB is FDA's classification for "Saw, powered, and accessories" (general, Plastic Surgery panel), a class 1 device. 9,977 medical device reports carry this product code, 0% of the MAUDE database, from May 1992 to August 2026.

484 reports arrived in the 12 months to August 2026, close to the 477 of 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 (95.5%) and injury (4.4%). 16 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
Motor Drive Unit Hand Cntrl Pwrmx El	5,167	208	0%	99.2%
Svc Repl Mdu Hand Cntrl Pwrmx	1,253	24	0%	99.8%
Svce Repl Mdu Cntrl Pwrmx Elite	207	0	0%	100%
Dyonics Powermini With Hand Controls	177	17	0%	95.5%
Cast Cutter	163	0	0%	93.5%
Universal Modular Electric/Battery Double	40	0	0%	100%
Universal Oscillating Saw Attachment	28	0	0%	98.3%
Dii Controller	10	6	0%	96.3%
Fast-Fix 360 Curved Ndl Delivery Sys	7	1,755	0%	79.1%
Tbd	4	8	0.6%	72.7%
Fa Quantum 2 Controller	2	3	0%	90.7%
Control Unit Dyonics 25	1	41	0%	87.8%
Footprint Ultra Pk Suture Anchor 4 5	1	147	0%	69.1%
Micro Sagittal Saw	1	0	0%	99.4%
Sagittal Blade	1	0	0%	89.6%
Twinfix Ti 5 0 Ultrabraid	1	11	0%	64%

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
Smith & Nephew	8,871	88.9%
Zimmer Surgical	367	3.7%
Stryker Instruments Kalamazoo	97	1%
Stryker Instruments-Kalamazoo	83	0.8%
Stryker Instruments	19	0.2%
Arthrocare	14	0.1%
Conmed	10	0.1%
Conmed Linvatec	5	0.1%
Stryker	4	0%
Stryker Ireland	4	0%
Aesculap	2	0%
Smith & Nephew Endoscopy Division	2	0%
Stryker Sustainability Solutions Lakeland	2	0%
Arjo Hospital Equipment	1	0%

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%3

Injury4.4%435

Malfunction95.5%9,532

Other0%2

Not given0.1%5

Who filed

Manufacturer report99.7%9,943

Voluntary report0.2%15

User facility report0%0

Distributor report0%0

Not given0.2%19

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

Device problems coded

Device problem (FDA code)	Reports	Share
Overheating of device	4,649	46.6%
Mechanical jam	1,989	19.9%
Mechanical problema mechanical problem	561	5.6%
Metal shedding debris	530	5.3%
Temperature problem	400	4%
Protective measures problem	364	3.6%
Noise, audible	334	3.3%
Breakthe device broke	316	3.2%
Insufficient device problem information	226	2.3%
Flaked	207	2.1%
Electrical shorting	201	2%
Material fragmentation	185	1.9%
Device operates differently than expectedthe device behaved unexpectedly	181	1.8%
Device inoperablethe device could not be used	137	1.4%
Electrical /electronic property probleman electrical or electronic problem	121	1.2%
Physical resistance/sticking	104	1%
Self-activation or keying	103	1%
Smoking	83	0.8%
Sparking	64	0.6%
Device displays incorrect message	63	0.6%

Questions about saw, powered, and accessories reports

What is product code HAB?

FDA's classification code for "Saw, powered, and accessories", 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?

9,977 reports through August 2026, 484 of them in the latest 12 months.

Which brands appear most often?

Motor Drive Unit Hand Cntrl Pwrmx El (5,167), Svc Repl Mdu Hand Cntrl Pwrmx (1,253), Svce Repl Mdu Cntrl Pwrmx Elite (207), Dyonics Powermini With Hand Controls (177) and Cast Cutter (163). 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.