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

Model Number 8488953

Device Problem Solder Joint Fracture (2324)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event 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.".

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
• Type of Device: 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
• MDR Text Key: 313399835
• Report Number: 9611102-2023-00022
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 04055207017838
• UDI-Public: 04055207017838
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K953868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2022
• 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
• Patient Outcome(s): Other