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 2020-02-24 for POWER MODULE FOR TRAUMA RECON SYSTEM 05.001.202 manufactured by Depuy Synthes Products Llc.
[188242834]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188242835]
It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the power module device stopped working minutes after using the device. It was reported that there were no delays in the procedure due to the event. It was reported that there was a spare device available for use and the procedure was successfully completed. There was patient involvement reported. There were no reports of any 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
| Report Number | 8030965-2020-01135 |
| MDR Report Key | 9745718 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2015-09-10 |
| Date Added to Maude | 2020-02-24 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWER MODULE FOR TRAUMA RECON SYSTEM |
| Generic Name | BATTERY, REPLACEMENT, RECHARGEABLE |
| Product Code | MOQ |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-02-19 |
| Catalog Number | 05.001.202 |
| 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 PRODUCTS LLC |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |