MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGASYSTEM-C; HEX SCREWDRIVER, HEX 2 MM, STAINLESS STEEL, WITH METAL HANDLE

Model Number	64-1181/16
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the 2.0 mm hex screwdriver broke off when screwing in the connecting component.
Additional Manufacturer Narrative
The review of this device history record is currently not possible due to temporarily unavailable archive data.The investigation is based on the visual inspection of the complaint sample provided.This visual inspection is considered sufficient to analyze the extent of the error.This is the final supplemental report, the complaint is closed.
Event or Problem Description
The tip of the 2.0 mm hex screwdriver broke off when screwing in the connecting component.[customer].

• Brand Name: MEGASYSTEM-C
• Common Device Name: HEX SCREWDRIVER, HEX 2 MM, STAINLESS STEEL, WITH METAL HANDLE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 18542258
• Report Number: 3004371426-2024-00009
• Device Sequence Number: 15398544
• Product Code: HXX
• UDI-Device Identifier: 04026575397044
• UDI-Public: 04026575397044
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 64-1181/16
• Device Catalogue Number: 64-1181/16
• Device Lot Number: C310022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown