MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGASYSTEM-C; HEX SCREWDRIVER, STAINLESS STEEL, L= 175 MM, ØSW 2.0 MM

Model Number 64-1181/06

Device Problem Fracture (1260)

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

Event Date 04/11/2024

Event Type  malfunction  

Event Description

The screwdriver broke when they were putting the set screw into the coupler, at the back table.Customer].

• Brand Name: MEGASYSTEM-C
• Type of Device: HEX SCREWDRIVER, STAINLESS STEEL, L= 175 MM, ØSW 2.0 MM
• 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: 19131820
• MDR Text Key: 341464989
• Report Number: 3004371426-2024-00034
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00402657511375
• UDI-Public: 0402657511375
• 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
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 64-1181/06
• Device Catalogue Number: 64-1181/06
• Device Lot Number: C312094
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1