MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-23 for MODIFIED TRINKLE REDUCTION DRIVE UNIT 532.020 manufactured by Depuy Synthes Products Llc.
[98193218]
The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. 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
[98193219]
It was reported that during an unspecified surgical procedure, it was observed that the attachment device had tight movement and was not operating correctly. There were no delays in the surgical procedure as an unspecified spare device was available for use. There was patient involvement. There were no injuries, medical intervention or prolonged hospitalization. The exact date of the event was not reported. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-50581 |
| MDR Report Key | 7213799 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-23 |
| Date of Report | 2017-12-26 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2018-02-13 |
| Device Manufacturer Date | 2004-02-13 |
| Date Added to Maude | 2018-01-23 |
| 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 | MR. 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 | 3 |
| Brand Name | MODIFIED TRINKLE REDUCTION DRIVE UNIT |
| Generic Name | DRIVER, SURGICAL, PIN |
| Product Code | GFC |
| Date Received | 2018-01-23 |
| Returned To Mfg | 2018-01-04 |
| Catalog Number | 532.020 |
| Lot Number | MA1008 |
| 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 | 2018-01-23 |