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	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note on exceeding the reporting deadline: reporting deadline 07 january 2024.Reporting date 19 january 2024.This initial report is delayed due to an it security-related incident from 18 december 2023.Due to the incident, we did not have access to our it systems and were temporarily unable to meet our obligation to report incidents on time.The process-relevant functions have been available again since 16 january 2024.Accordingly the reports will now be submitted retrospectively.The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
The tip of the 2.0 mm hex screwdriver broke off when screwing in the connecting component.
Event or Problem Description
The tip of the 2.0 mm hex screwdriver broke off when screwing in the connecting component.[customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final supplemental report, the complaint is closed.

• 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: 18542256
• Report Number: 3004371426-2024-00008
• Device Sequence Number: 20778300
• 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): 12/08/2023

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: C206066
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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