MAUDE Adverse Event Report: RAIMUND WENZLER GMBH BEYER RONGEUR FORCEPS; FORCEPS, ENT

Catalog Number AU6790 / RW8950

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: BEYER RONGEUR FORCEPS
• Type of Device: FORCEPS, ENT
• Manufacturer (Section D): RAIMUND WENZLER GMBH; steigaecker 22; balgheim, baden-wuerttemberg 78582 ; GM 78582
• Manufacturer (Section G): RAIMUND WENZLER GMBH; steigaecker 22; balgheim, baden-wuerttemberg 78582 ; GM 78582
• Manufacturer Contact: martin wenzler ; steigaecker 22; balgheim, baden-wuerttemberg 78582 ; GM 78582 ; 4249582738
• MDR Report Key: 5767938
• MDR Text Key: 49497653
• Report Number: 9611616-2016-00003
• Device Sequence Number: 1
• Product Code: KAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: AU6790 / RW8950
• Device Lot Number: 27062606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1