MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-11 for BATTERY HANDPIECE/MODULAR FOR TRS 05.001.201 manufactured by Depuy Synthes Products Llc.
[111202603]
(b)(6). This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the reported condition was confirmed. The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[111202604]
It was reported by (b)(6) that during service and evaluation, it was determined that the bearing of the battery handpiece/modular device was not functioning and was defective. It was further determined that the device had excessive dirt and oxidation internally. It was determined that the failure was due to cleaning and lubrication issues. It was observed that the device had limited functions and non-characteristic noises. It was noted in the service order that the device had no power. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2018. All available information has been disclosed. If additional information should available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-54245 |
| MDR Report Key | 7588131 |
| Date Received | 2018-06-11 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-06-18 |
| Device Manufacturer Date | 2014-03-11 |
| Date Added to Maude | 2018-06-11 |
| 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 | SYNTHES PRODUKTIONS GMBH |
| Manufacturer Street | HAUPTSTRASSE 24 |
| Manufacturer City | WALDENBURG 4437 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BATTERY HANDPIECE/MODULAR FOR TRS |
| Generic Name | MOTOR, SURGICAL INSTRUMENT, AC-POWERED |
| Product Code | DEY |
| Date Received | 2018-06-11 |
| Returned To Mfg | 2018-04-26 |
| Catalog Number | 05.001.201 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-06-11 |