MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 90MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	3362-5-090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/08/2019
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
It was reported that the omega lag screw broke upon insertion into the patient.The breakage was observed during the last half-turn of the screw.
Event or Problem Description
It was reported that the omega lag screw broke upon insertion into the patient.The breakage was observed during the last half-turn of the screw.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: both positioning grooves of the end part of the lag screw are clearly badly damaged (deformed and spread out).It indicates that either the lag screw had not been properly assembled with the lag screw adapter or just inadequate use (overtightening) has resulted in these deformations.The threaded part of the lag screw is still intact though.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.Based on investigation, the root cause was attributed to be user related.The failure was most probably caused by an overtightening.If any further information is provided, the investigation report will be updated.

• Brand Name: STANDARD LAG SCREW OMEGA 90MM 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: 9458171
• Report Number: 0008031020-2019-02135
• Device Sequence Number: 19593022
• Product Code: KTT
• UDI-Device Identifier: 07613327093025
• UDI-Public: 07613327093025
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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: 07/31/2024
• Device Model Number: 3362-5-090
• Device Catalogue Number: 33625090
• Device Lot Number: B94456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1