MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-04 for BEYER RONGEUR FORCEPS AU6790 / RW8950 manufactured by Raimund Wenzler Gmbh.
[49497653]
Device subject to unauthorized modification, including removal of material on distal end by grinding or filing, thus weakening tip. Manufacturing records reviewed and found conforming.
Patient Sequence No: 1, Text Type: N, H10
[49497654]
The instrument was being used during an orif procedure, trimming bone when the tip broke. When asked if the broken piece had to be retrieved from the patient, the user facility answered "n/a". Another device was required to complete the procedure. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611616-2016-00003 |
| MDR Report Key | 5767938 |
| Date Received | 2016-07-04 |
| Date of Report | 2016-07-04 |
| Date Mfgr Received | 2015-04-16 |
| Device Manufacturer Date | 2006-11-08 |
| Date Added to Maude | 2016-07-04 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARTIN WENZLER |
| Manufacturer Street | STEIGAECKER 22 |
| Manufacturer City | BALGHEIM, BADEN-WUERTTEMBERG 78582 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78582 |
| Manufacturer Phone | 4249582738 |
| Manufacturer G1 | RAIMUND WENZLER GMBH |
| Manufacturer Street | STEIGAECKER 22 |
| Manufacturer City | BALGHEIM, BADEN-WUERTTEMBERG 78582 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BEYER RONGEUR FORCEPS |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2016-07-04 |
| Returned To Mfg | 2015-04-20 |
| Catalog Number | AU6790 / RW8950 |
| Lot Number | 27062606 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAIMUND WENZLER GMBH |
| Manufacturer Address | STEIGAECKER 22 BALGHEIM, BADEN-WUERTTEMBERG 78582 GM 78582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-04 |