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

Model Number	8488096
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Common Device Name: 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
• Report Number: 9611102-2023-00075
• Device Sequence Number: 11431680
• Product Code: NBH
• UDI-Device Identifier: 04055207042632
• UDI-Public: 04055207042632
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown