MAUDE Adverse Event Report: WALDEMAR LINK GMBH CO. KG HEX SCREWDRIVER, HEX 2.0MM, 175MM

Model Number 64-1181/06

Device Problems Fracture (1260); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2013

Event Type  malfunction  

Manufacturer Narrative

All product features correspond with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.The visual inspection of the complaint sample confirms the described defect.It is most likely that mechanical overload while tightening the hex screw resulted in the breakage of the tip.Due to the small diameter of 2.0mm of the tip, well dosed application of forces is required.In case a customer does not feel comfortable using this screwdriver we are able to source a screwdriver ((b)(4)) with a pre-defined moment of torque.This event occured outside of the u.S.And involves a product that was manufactured outside of the u.S.However, because the affected product is also marketed in the u.S., waldemar link (b)(4) is submitting this mdr to ensure full compliance with 21 cfr part 803.(b)(4).

Event Description

While 1st tightening the tip of the 2mm hex, driver snapped off, leaving most of the tip still within the screw head.The tip was still long enough to tighten the overlying screw.The operation was therefore not extended in time and patient came to no harm.

• Brand Name: HEX SCREWDRIVER, HEX 2.0MM, 175MM
• Type of Device: HEX SCREWDRIVER
• Manufacturer (Section D): WALDEMAR LINK GMBH CO. KG; hamburg 22339 ; GM 22339
• Manufacturer (Section G): WALDEMAR LINK GMBH CO. KG; oststrasse 410; norderstedt
• Manufacturer Contact: philipp kottmann ; barkhausenweg 10; hamburg ; GM ; 053575432
• MDR Report Key: 6428053
• MDR Text Key: 71206051
• Report Number: 3004371426-2013-00004
• Device Sequence Number: 0
• Product Code: HXX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Risk Manager
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 64-1181/06
• Device Catalogue Number: 64-1181/06
• Device Lot Number: B141177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2013
• Date Manufacturer Received: 07/31/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention