Devices › Motor, surgical instrument, ac-powered
Device brand name · Motor surgical instrument ac-powered
Batt-Handpiece Recon Sagittal Saw W/T-Ha: medical device reports filed with FDA
199 reports name it, 2014–2017. Manufacturer given most often on reports: Depuy Synthes Power Tools. Product code GEY.
- 199
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.5%
- classified as malfunction
- 99.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 199 reports that name the brand "Batt-Handpiece Recon Sagittal Saw W/T-Ha" (motor surgical instrument ac-powered), received between January 2014 and December 2017; the manufacturer given most often on reports is Depuy Synthes Power Tools. 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 (99.5%) and injury (0.5%); across all motor, surgical instrument, ac-powered reports (product code GEY) death is recorded in 0% and malfunction in 99.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unintended system motion (40.2%), fail-safe problem (39.2%) and mechanical jam (18.1%). The patient problems coded most often are no patient involvement, hematoma and swelling. 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 Batt-Handpiece Recon Sagittal Saw W/T-Ha was received in the five years to August 2026; the latest was received in December 2017.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 18,245 reports carrying product code GEY. 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 |
|---|---|---|---|
| Unintended system motionthe device moved when it should not have | 80 | 40.2% | 10.9% |
| Fail-safe problem | 78 | 39.2% | 7.5% |
| Mechanical jam | 36 | 18.1% | 15.5% |
| Device inoperablethe device could not be used | 26 | 13.1% | 7.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 22 | 11.1% | 5.9% |
| Breakthe device broke | 12 | 6% | 4.7% |
| Defective component | 11 | 5.5% | 0.9% |
| Leak/splashthe device leaked | 10 | 5% | 4.5% |
| Overheating of device | 8 | 4% | 2.2% |
| Defective devicethe device was defective | 7 | 3.5% | 1% |
| Partial blockage | 5 | 2.5% | 2.1% |
| Difficult to position | 4 | 2% | 0.1% |
| Mechanical problema mechanical problem | 4 | 2% | 1.6% |
| Naturally worn | 4 | 2% | 1.1% |
| Noise, audible | 4 | 2% | 4.3% |
| Sticking | 3 | 1.5% | 1.6% |
| Connection problema connection problem | 2 | 1% | 0.3% |
| Device stops intermittentlythe device stopped now and then | 2 | 1% | 0.7% |
| Fitting problem | 2 | 1% | 0.1% |
| Incorrect or inadequate test results | 2 | 1% | 0.3% |
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 | 116 | 58.3% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.5% |
| Swellingswelling | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Batt-Handpiece Recon Sagittal Saw W/T-Ha | Product code GEY | All MAUDE reports |
|---|---|---|---|
| Reports | 199 | 18,245 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.5% | 0.7% | 36.2% |
| Classified as malfunction | 99.5% | 99.3% | 62.3% |
| Filed by the manufacturer | 100% | 99.8% | 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 GEY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Battery Handpiece/Modular For Trs | 2,591 | 213 | 0% |
| Emax 2 Plus Motor | 8,860 | 62 | 0% |
| Batt-Handpiece Mod F/Trs | 1,217 | 0 | 0% |
| Power Drive | 936 | 0 | 0% |
| Battery Oscillator | 840 | 0 | 0% |
| Battery Reamer/Drill | 774 | 0 | 0% |
| Recon Sagittal Saw With Key For Trs | 418 | 21 | 0% |
| Kincise Automated Surgical Impactor | 397 | 11 | 0% |
| Chuck With Key F/Bpl | 285 | 37 | 0% |
| Kincise Pinnacle Shell/Liner Impactor | 191 | 11 | 0% |
| Universal Modular Electric/Battery Double | 238 | 0 | 0% |
| Universal Oscillating Saw Attachment | 236 | 0 | 0% |
| Chuck With Key/Drill Speed For Trs | 655 | 94 | 0% |
| Power Module F/Trs | 566 | 0 | 0% |
| 12 4cm Heavy Duty Long Attch | 183 | 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 Batt-Handpiece Recon Sagittal Saw W/T-Ha reports
How many FDA reports name Batt-Handpiece Recon Sagittal Saw W/T-Ha?
199 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 (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unintended system motion (40.2%), fail-safe problem (39.2%), mechanical jam (18.1%), device inoperable (13.1%) and device operates differently than expected (11.1%). 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 Batt-Handpiece Recon Sagittal Saw W/T-Ha 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.