MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 95MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	33625095
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.Device remains implanted.
Event or Problem 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.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Unfortunately the x-rays do not reveal any damages.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem 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.

• Brand Name: STANDARD LAG SCREW OMEGA 95MM LENGTH
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8729116
• Report Number: 0008031020-2019-00725
• Device Sequence Number: 19475988
• Product Code: KTT
• UDI-Device Identifier: 07613327093032
• UDI-Public: 07613327093032
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K955306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 33625095
• Device Lot Number: B88132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1