MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L50MM; PLATE, FIXATION, BONE

Catalog Number	657450
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2018
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
It was reported that as the screw was being removed to be changed for shorter one, the threads sheared off completely.
Additional Manufacturer Narrative
The reported event that bone screw variax2 t10, full thread, 3.5mm / l50mm was alleged of 'device stripped/twisted' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much applied torsional force during screw removal.The device inspection revealed the following: that some pieces of swarf were indeed getting uncoiled during screw removal.Note that the screw is damaged on the inner edge of the thread approximately 3/4 of the screw length which clearly indicates that the uncoiling took place during the screw removal.As mentioned; the surgeon stopped and decided, as the wrong screw was being chosen (too long) and a shorter screw was exchanged instead.The length of the swarf lead us believe that the screw was positioned on an unfavorable angle so that the material was getting uncoiled during removal (high torsional force).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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that as the screw was being removed to be changed for shorter one, the threads sheared off completely.

• Brand Name: BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L50MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8084408
• Report Number: 0008031020-2018-00991
• Device Sequence Number: 1437786
• Product Code: HRS
• UDI-Device Identifier: 07613327074260
• UDI-Public: 07613327074260
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132502
• 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): 01/03/2019

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 Catalogue Number: 657450
• Device Lot Number: L51224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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