MAUDE Adverse Event Report: STRYKER GMBH STANDARD LAG SCREW OMEGA 110MM LENGTH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	3362-5-110
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "omega lag screw tabs deformed as lag screw was being inserted into patient.Had to remove & put in a shorter screw.Surgeon tapped before insertion.".
Event or Problem Description
As reported: "omega lag screw tabs deformed as lag screw was being inserted into patient.Had to remove & put in a shorter screw.Surgeon tapped before insertion.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: device disposition unknown.

• Brand Name: STANDARD LAG SCREW OMEGA 110MM LENGTH
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15925087
• Report Number: 0008031020-2022-00668
• Device Sequence Number: 20090528
• Product Code: KTT
• UDI-Device Identifier: 07613327092899
• UDI-Public: 07613327092899
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K955306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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 Model Number: 3362-5-110
• Device Catalogue Number: 33625110
• Device Lot Number: C11014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown