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	Injury (2348)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that standard lag screw omega 110mm length was alleged of issue ¿implant - deformation intra-operative¿ could be confirmed with the pictures provided.Device inspection revealed the following: the picture shows the damages / deformations of the end part of the lag screw.It indicates that either the lag screw had not been properly assembled with the lag screw adapter or just inadequate use has resulted in these deformations.The lag screw also presents scratches/marks, probably caused due to friction with the bone during insertion.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.Certificate of conformance was reviewed which declares that the product complies with the contract requirements and that, after completion of testing and verification, it completely satisfy all specified requirements, and applicable standards and regulations.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is user related.Comments from the representative ¿the bone of the patient was harder than a usual elderly patient although no harder than a younger patient.There looked to be considerable torque being applied though.Tapping was suggested by myself but not conducted.¿ as indicated by the above comments of the representative, the damages / deformations of the end part of the lag screw seems to be due to high torque applied by the user in the relatively hard bone of the patient.If any additional information is provided, the investigation will be reassessed.Device discarded.
Event or Problem Description
As reported: "the end of the omega lag screw stripped on insertion and in the same case, the plate impactor snapped.Plate impactor snapped during use.No replacement was available, a bristow wedged in the notch was used in place." additionally reported: "a larger incision was needed.The procedure took longer to replace the lag screw.15min surgical delay.Improvisation was needed to seat the plate on the bone.A bristow wedged in the notch was used in place." "the larger incision was made due to the screw stripping first trying to ¿helicopter¿ the screw around using the plate and barrel.A larger incision was also needed because it was more difficult to seat the plate through the tissue without the impactor.".

• 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 ; CH 2545
• MDR Report Key: 10135897
• Report Number: 0008031020-2020-01564
• Device Sequence Number: 3184638
• Product Code: KTT
• UDI-Device Identifier: 07613327092899
• UDI-Public: 07613327092899
• 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): 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 3362-5-110
• Device Catalogue Number: 33625110
• Device Lot Number: B97422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/09/2020
• 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
• Patient Age: 68 YR