MAUDE Adverse Event Report: RICHARD WOLF GMBH; GRASPING FORCEPS Ø 3.4MM

Model Number 8488096

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

The grasping forceps 3.4mm, part id: 8488.096 comes from production batch 1530418.The batch consists of 9 forceps.As of 21 december 2023, we have not received any further complaints about this batch.

Event Description

A healthcare professional has informed richard wolf gmbh (rwgmbh) of an issue regarding a grasping forceps ø 3.4mm, part id: 8488.096, lot # 1530418.According to the received information, during a knee arthroscopy when packing a resected section of the meniscus, the lower jaw part in the joint broke off.The surgeon then performed a miniarthrotomy (joint opening).The fragment of the forceps was completely retrieved.

• Type of Device: GRASPING FORCEPS Ø 3.4MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 18384742
• MDR Text Key: 331295050
• Report Number: 9611102-2023-00075
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 04055207042632
• UDI-Public: 04055207042632
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8488096
• Device Catalogue Number: 8488.096
• Device Lot Number: 1530418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other