MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-02-09 for ADAPTER F/OILING 519.790 manufactured by Depuy Synthes Power Tools.
[67242138]
(b)(6). 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
[67242139]
It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the adaptor device had an undetermined malfunction. It was not reported if there was a delay in the procedure due to the event, or if a spare device was available for use. There was patient involvement reported. There were no patient or user injuries reported. It was reported there was no 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
[74729838]
Additional narrative: (b)(4). The actual device was returned for evaluation. The adapter device was evaluated and identified no failure. Therefore, the reported condition was not confirmed. An assignable root cause was not determined. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2017-10673 |
| MDR Report Key | 6314217 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-09 |
| Date of Report | 2017-01-23 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2017-02-09 |
| 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 | MICHAEL COTE |
| 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 | ADAPTER F/OILING |
| Generic Name | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2017-02-09 |
| Returned To Mfg | 2017-02-01 |
| Catalog Number | 519.790 |
| Lot Number | N/I |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-02-09 |