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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG HEX SCREWDRIVER; 2.0 MM HEX SCREWDRIVER
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WALDEMAR LINK GMBH & CO. KG HEX SCREWDRIVER; 2.0 MM HEX SCREWDRIVER Back to Search Results
Model Number 64-1181/16
Device Problems Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017); Naturally Worn (2988); Misassembly by Users (3133); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2018
Event Type  malfunction  
Manufacturer Narrative
The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the (b)(4) at the time period, when the item was produced.
 
Event Description
Locking screw for stem couldn't be used due to stripped hex screw driver.This resulted in delay in surgery by 20-30 min and didn't allow the surgeon to lock the stem.The surgeon deviated from the surgical technique and used cement instead of a screw to lock the stem on to the femoral prosthesis.The complaint description was received by the linkbio complaint department on (b)(6) 2018.
 
Manufacturer Narrative
The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.The visual inspection confirms several traces of wear regarding the tip and the surface of the screwdriver.The tip of the screwdriver is slightly deformed due to frequent use.Inserting the screwdriver and turning the screw is therefore difficult.The returned hex screwdriver has a different lot number than complained.The ifu requires that instruments must be tested for their fitness for operation and their functional efficiency every time before they are used.In particular areas and functions such as shapes and tips should be checked.The service life of instruments depends on materials, design, use, and processing.Furthermore, locking with cement does not achieve the required properties to secure the taper connection.
 
Event Description
Locking screw for stem couldn't be used due to stripped hex screw driver.This resulted in delay in surgery by 20-30 min and didn't allow the surgeon to lock the stem.The surgeon deviated from the surgical technique and used cement instead of a screw to lock the stem on to the femoral prosthesis.The complaint description was received by the linkbio complaint department on (b)(6) 2018.
 
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Brand Name
HEX SCREWDRIVER
Type of Device
2.0 MM HEX SCREWDRIVER
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key8008128
MDR Text Key125109788
Report Number3004371426-2018-00013
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K151008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number64-1181/16
Device Catalogue Number64-1181/16
Device Lot NumberB422023 (RETURNED B618078)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2018
Date Manufacturer Received09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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