MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-10 for UNKNOWN manufactured by Depuy Synthes Power Tools.
[33781008]
The lot/serial number and manufacturing location are unknown. Device manufacture date: the device manufacture date is unavailable. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[33781009]
It was reported that during an unspecified surgical procedure it was observed that the tip of an unknown burr device broke off inside the angle driver device. The reporter stated that the burr has not been completely removed from the device. It was not reported if there were any delays in a surgical procedure or if a spare device was available. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[35115522]
The actual device was not returned for evaluation. The investigation was performed based on the other two devices that were returned. It was determined that the tip of the broke burr device was found inside of the returned attachment device. It was determined that the piece of the broken burr device was the lower part of the device and was approximately 1 1/2" long. Therefore, the reported condition was confirmed. It was determined that this was indicative of applying to much force on the cutter while in use thus compromising internal components of the attachment device. The assignable root cause was determined to be due misuse, abuse and/or error. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-17745 |
| MDR Report Key | 5286030 |
| Date Received | 2015-12-10 |
| Date of Report | 2015-11-24 |
| Date of Event | 2015-11-23 |
| Date Mfgr Received | 2015-12-22 |
| Date Added to Maude | 2015-12-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | NI |
| Manufacturer City | NI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | HTT |
| Date Received | 2015-12-10 |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | NI NI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-10 |