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].

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 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

• 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
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/18/2024
• 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