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

Model Number	3362-5-105
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event that standard lag screw omega 105mm length was alleged of device deformed could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A deformation of the lag screw can occur if; either the lag screw had not been properly assembled with the lag screw adapter or just inadequate use (over tightening) has resulted in such described deformations.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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device is not available to stryker.
Event or Problem Description
While inserting an omega3, 4 hole plate and 105mm lag screw, the surgeon struggled to get the plate to slide over the lag screw.Upon closer inspection the surgeon noticed that the tabs on the lag screw had sheared off during final insertion.The op tech had been followed, lag screw was drilled and tapped prior to insertion.

• 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: 7203667
• Report Number: 0008031020-2018-00046
• Device Sequence Number: 722962
• Product Code: KTT
• UDI-Device Identifier: 07613327092882
• UDI-Public: (01)07613327092882(17)220630(10)L13774
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K955306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2018

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: 06/30/2022
• Device Model Number: 3362-5-105
• Device Catalogue Number: 33625105
• Device Lot Number: L13774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other