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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN LAG SCREW INSERTER; INSTRUMENT
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STRYKER GMBH UNKNOWN LAG SCREW INSERTER; INSTRUMENT Back to Search Results
Catalog Number UNK_SEL
Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2019
Event Type  malfunction  
Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
 
Event Description
The customer reported that problems were encountered with the final turn of the lag screw inserter.The bone was hard and the surgeons had tapped to account for this.When measuring for the lag screw they had taken 5 off the measurement and therefore over reamed.When trying to turn the lag screw handle parallel to allow the plate to pass over the lag screw and sit onto the near cortex, the lag screw implant sheared off the insertion device and became bent/twisted.This meant it was then impossible to remove the lag screw and it had to be manipulated to allow the plate to pass over the top of it and into place.The operation was completed and it added around 1 hour to the operating time.No pieces fell into the wound.The lag screw was already inserted when the issue was discovered.The decision was made that it would be clinically safer to leave the screw in situ rather than remove it.The customer reported that the lag screw inserter is functional.The patient¿s bone quality was good, hence the reason the surgeon tapped the bone before he inserted the lag screw.The patient had a general anaesthetic and a regional block so no additional analgesia was needed.However the patient was anaesthetised for longer than would normally be necessary for this type of procedure.
 
Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
 
Event Description
The customer reported that problems were encountered with the final turn of the lag screw inserter.The bone was hard and the surgeons had tapped to account for this.When measuring for the lag screw they had taken 5 off the measurement and therefore over reamed.When trying to turn the lag screw handle parallel to allow the plate to pass over the lag screw and sit onto the near cortex, the lag screw implant sheared off the insertion device and became bent/twisted.This meant it was then impossible to remove the lag screw and it had to be manipulated to allow the plate to pass over the top of it and into place.The operation was completed and it added around 1 hour to the operating time.No pieces fell into the wound.The lag screw was already inserted when the issue was discovered.The decision was made that it would be clinically safer to leave the screw in situ rather than remove it.The customer reported that the lag screw inserter is functional.The patient¿s bone quality was good, hence the reason the surgeon tapped the bone before he inserted the lag screw.The patient had a general anaesthetic and a regional block so no additional analgesia was needed.However the patient was anaesthetised for longer than would normally be necessary for this type of procedure.
 
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Brand Name
UNKNOWN LAG SCREW INSERTER
Type of Device
INSTRUMENT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8729113
MDR Text Key149179720
Report Number0008031020-2019-00724
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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