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

Model Number 64-1181/06

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2013

Event Type  malfunction  

Event Description

Whilst 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.

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 2.0 mm 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 (art.No 15-2545) with a pre-defined moment of torque.This event occurred 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).

• Brand Name: HEX SCREWDRIVER, HEX 2.0 MM, 175 MM
• Type of Device: HEX SCREWDRIVER
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; hamburg 2233 9; GM 22339
• Manufacturer Contact: philipp kottmann ; barkhausenweg 10; hamburg 22339 ; GM 22339 ; 053575432
• MDR Report Key: 4272940
• MDR Text Key: 5231468
• Report Number: 3004371426-2014-00002
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/06/2014
• Is this an Adverse Event Report?: No
• 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
• Other Device ID Number: GMDN: 32781
• Was Device Available for Evaluation?: Yes
• 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
• Patient Sequence Number: 1
• Treatment: LINK ENDO ROTATIONAL MODULAR KNEE SYSTEM
• Patient Outcome(s): Required Intervention