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

Device Problems Fracture (1260); Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  malfunction  

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 Description

The tip of the 2.0 mm hex screwdriver broke off when screwing in the connecting component.

Event Description

The tip of the 2.0 mm hex screwdriver broke off when screwing in the connecting component.[customer].

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
• Type of Device: 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
• MDR Text Key: 333227059
• Report Number: 3004371426-2024-00008
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 04026575397044
• UDI-Public: 04026575397044
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• 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