MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 105MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	33625105
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that the lag screw sheared off in the insertion device.No adverse consequence or surgical delay was reported.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate use.The device inspection revealed the following: the returned lag screw was confirmed to be severely damage / deformed (both connection pins are splayed open).This clearly indicates that either the lag screw had not been properly assembled with the lag screw adapter (got loose) or just inadequate use has resulted in these deformations.Note: the lag screw should be centered in the head on both anterior-posterior and lateral views, within 10 millimeters of subchondral bone.Application of the template to an x-ray of the uninvolved hip may help simulate reduction of the fractured hip.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 any further information is provided, the investigation report will be updated.
Event or Problem Description
The customer reported that the lag screw sheared off in the insertion device.No adverse consequence or surgical delay was reported.

• Brand Name: STANDARD LAG SCREW OMEGA 105MM 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: 8729117
• Report Number: 0008031020-2019-00726
• Device Sequence Number: 11422323
• Product Code: KTT
• UDI-Device Identifier: 07613327092882
• UDI-Public: 07613327092882
• 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: 01/31/2024
• Device Catalogue Number: 33625105
• Device Lot Number: B90658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• 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