MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-15 for DRILL BIT UNK_PRODUCT manufactured by Depuy Synthes Power Tools.
[55206082]
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
[55206083]
This is event 2 of 2 of the same event. It was reported from (b)(6) that during surgery for a tibial diaphysis fracture, it was observed that smoke came out from the part of the radiolucent drive device where it was spinning the drill bit device. According to the report, the radiolucent drive device and the drill bit device started running idle when the surgeon tried to perform distal locking. The surgeon stated that it might have been due to low power on the radiolucent drive device which caused that drill bit device to not spin. There was a ten minute delay to the surgical procedure. It was unknown if a spare device was available for use. There was patient involvement. 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
[56582067]
During subsequent follow-up, the reported stated that the procedure was performed on an elderly person. It was also mentioned that the drill device was not new and therefore did not work smoothly. 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 | 2520274-2016-14541 |
| MDR Report Key | 5953084 |
| Date Received | 2016-09-15 |
| Date of Report | 2016-09-01 |
| Date of Event | 2016-08-29 |
| Date Mfgr Received | 2016-09-21 |
| Date Added to Maude | 2016-09-15 |
| 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 | MARK VORNHEDER |
| 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 | N/I |
| Manufacturer City | N/I |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL BIT |
| Generic Name | UNKNOWN |
| Product Code | HXY |
| Date Received | 2016-09-15 |
| Catalog Number | UNK_PRODUCT |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | N/I N/I US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-15 |