Device manufacturer, as written on reports
Synthes Oberdorf: medical device reports filed with FDA
8,189 reports name it as the manufacturer of the device involved, 2011–2018.
- 8,189
- reports naming it as manufacturer
- 0% of all MAUDE reports
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.2%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
8,189 medical device reports received by FDA give Synthes Oberdorf as the manufacturer of the device involved, 0% of the MAUDE database, from May 2011 to January 2018. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
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 (99.2%) and injury (0.8%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| Small Battery Drive | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 657 | 0 | 0% |
| Power Drive | Motor, surgical instrument, ac-powered | 521 | 0 | 0% |
| Colibri | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 328 | 0 | 0% |
| Batt-Handpiece Mod F/Trs | Motor, surgical instrument, ac-powered | 277 | 0 | 0% |
| Power Module F/Trs | Battery, replacement, rechargeable | 207 | 0 | 0% |
| Battery Oscillator | Motor, surgical instrument, ac-powered | 195 | 0 | 0% |
| Battery Reamer/Drill | Motor, surgical instrument, ac-powered | 167 | 0 | 0% |
| Battery Handpiece/Modular For Trs | Motor, surgical instrument, ac-powered | 154 | 213 | 0% |
| Epd 60000 Rpm | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 124 | 0 | 0% |
| Sagittal Saw Attachment | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 124 | 64 | 0% |
| Small Battery Drive Colibri | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 115 | 0 | 0% |
| Electric Pen Drive 60 000 Rpm | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 108 | 94 | 0% |
| Oscill-Saw-Attachm F/532 001 532 010 532 | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 100 | 0 | 0% |
| Air Oscillator | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 79 | 0 | 0% |
| Batt-Handpiece Recon Sagittal Saw W/T-Ha | Motor, surgical instrument, ac-powered | 75 | 0 | 0% |
| Radiolucent-Drive | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 67 | 0 | 0% |
| Quick Coupling For K-Wires | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 61 | 28 | 0% |
| Power Module For Trauma Recon System | Battery, replacement, rechargeable | 55 | 51 | 0% |
| Batt F/Nos 532 101+532 110 | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 54 | 0 | 0% |
| Sagitt Saw-Attachm Long W/T-Handle F/Trs | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 41 | 0 | 0% |
| Recon Sagittal Saw With Key For Trs | Motor, surgical instrument, ac-powered | 21 | 21 | 0% |
| Qc F/K-Wires 0 6-3 2 F/532 001 532 010 | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 20 | 0 | 0% |
| Air Pen Drive | Motor, drill, pneumatic | 17 | 22 | 0% |
| 2 0mm Rapid Resorbable Cortex Screw 4mm-Sterile | Plate, bone | 11 | 107 | 0% |
| Oscill-Saw | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 11 | 0 | 0% |
| Ni | Set, administration, for peritoneal dialysis, disposable | 9 | 1,587 | 1.8% |
Brands with a page on this site, 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."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| HWE | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 4,823 | 58.9% |
| GEY | Motor, surgical instrument, ac-powered | 2,385 | 29.1% |
| MOQ | Battery, replacement, rechargeable | 621 | 7.6% |
| GFA | Blade, saw, general & plastic surgery, surgical | 108 | 1.3% |
| HBB | Motor, drill, pneumatic | 44 | 0.5% |
| JEY | Plate, bone | 34 | 0.4% |
| HSZ | Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment | 16 | 0.2% |
| LXH | Orthopedic manual surgical instrument | 15 | 0.2% |
| HTJ | Gauge, depth | 9 | 0.1% |
| HTW | Bit, drill | 9 | 0.1% |
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
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Synthes Oberdorf reports
How many FDA device reports name Synthes Oberdorf as manufacturer?
8,189 reports through August 2026, 0 of them in the latest 12 months.
Which of its brands appear most often?
Small Battery Drive (657), Power Drive (521), Colibri (328), Batt-Handpiece Mod F/Trs (277) and Power Module F/Trs (207).
Which device types does it report on?
instrument, surgical, orthopedic, ac-powered motor and accessory/attachment (58.9%), motor, surgical instrument, ac-powered (29.1%), battery, replacement, rechargeable (7.6%) and blade, saw, general & plastic surgery, surgical (1.3%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."
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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.