MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L55MM; PLATE, FIXATION, BONE

Catalog Number	661055
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2018
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
The customer reported that during implantation of an axsos 3 tibial plate the surgeon noticed swarf building up around the head of the axsos 3 locking screw as he was inserting it by hand.On the x-ray the surgeon could see that debris had built up at the plate hole and the thread was no longer on the screw.Another screw was used to complete the case.All swarf was removed from the patient.There were no delays to the case.
Additional Manufacturer Narrative
The reported event that locking screw axsos 3 ti 4.0mm / l55mm was alleged of issue (breakage during surgery) could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection was done and it was found that the screw threads were shaved off along the entire length of the screw.Such a severe damage could be a result of wrong size selection of screw or misalignment of screw with the drilled hole axis leading to excessive torque application causing the thread damage.Thus, based on investigation, the root cause can be attributed to a user related issue.The failure was most likely caused by failure to follow the op-tech such as - selection of wrong length screw, failure to use a tap for hard bone before screw insertion, misalignment of screw with the drilled hole axis etc.And the excessive application of axial force during screw insertion led to deformation of screw threads.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 any further information is provided, the investigation report will be updated.
Event or Problem Description
The customer reported that during implantation of an axsos 3 tibial plate the surgeon noticed swarf building up around the head of the axsos 3 locking screw as he was inserting it by hand.On the x-ray the surgeon could see that debris had built up at the plate hole and the thread was no longer on the screw.Another screw was used to complete the case.All swarf was removed from the patient.There were no delays to the case.

• Brand Name: LOCKING SCREW AXSOS 3 TI 4.0MM / L55MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7606777
• Report Number: 0008031020-2018-00469
• Device Sequence Number: 2142181
• Product Code: HRS
• UDI-Device Identifier: 07613252579915
• UDI-Public: 07613252579915
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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: 05/31/2022
• Device Catalogue Number: 661055
• Device Lot Number: L25046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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: Required Intervention