MAUDE Adverse Event Report: RICHARD WOLF GMBH; HOOK PUNCH Ø 3.4MM

Model Number	8488953
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative has informed richard wolf gmbh an issue regarding a hook punch ø 3.4mm, part id: 8488953, batch # 1518877.According to the received information: "the instrument was broken when the doctor used it during the surgery.The surgery was delayed and could not be completed because of the broken instrument.".
Additional Manufacturer Narrative
The hook punch ø 3.4 mm 8488953 was investigated in the responsible department.During the inspection, the specialist department found that the solder joint between the tie rod and the joint was broken.The cause of the breakage at the solder joint is attributed to a poorly executed solder connection, as the solder flow was not homogeneous.Despite this failure, there is no functional impairment.Solder joints are subject to normal wear due to application and reprocessing.Pores in solder joints can accelerate this wear behavior.The hook punch ø 3.4 mm 8488953, batch # 1518877 was manufactured on 02/sep/2022.The batch consisted of 5 pieces.No issues were identified during production.No further complaints were received regarding this device.The ifu ga-s 003 / usa / 2013-06 v2.0 / eco 2013-0159 contains safety instructions regarding visual and functional checks prior each use and after each reprocessing to detect such damage or functional impairment in section 7 checks.The subject issue of breakage during use and not usable device is present in the risk management file b1-2: reusable non-optical forceps and scissors, rev.: r05.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: NA
• Common Device Name: HOOK PUNCH 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: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16678587
• Report Number: 9611102-2023-00022
• Device Sequence Number: 7989111
• Product Code: NBH
• UDI-Device Identifier: 04055207017838
• UDI-Public: 04055207017838
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K953868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8488953
• Device Catalogue Number: 8488.953
• Device Lot Number: 1518877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown