MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L48MM; PLATE, FIXATION, BONE

Catalog Number	657448S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2018
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
When inserting a screw, the thread stripped from screw.
Event or Problem Description
When inserting a screw, the thread stripped from screw.
Additional Manufacturer Narrative
The reported event that bone screw variax2 t10, full thread, 3.5mm / l48mm was alleged of 'device stripped/twisted' could be confirmed only looking at the picture though.Based on the received picture, the root cause was attributed to be user related.The failure was caused by possible inadequate angulations during screw insertion.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.Looking at the picture it revealed the following: that some metal was getting coiled up, possibly right after the first turn during screw insertion.The surgeon stopped approximately 3/4 of the screw length as he must have seen the metal piece hanging off.The length of the metal indicates that the screw was positioned on an unfavorable angle so that the material was getting coiled up.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L48MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7976366
• Report Number: 0008031020-2018-00875
• Device Sequence Number: 13525192
• Product Code: HRS
• UDI-Device Identifier: 07613327074253
• UDI-Public: 07613327074253
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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: 11/30/2021
• Device Catalogue Number: 657448S
• Device Lot Number: V50302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 12/14/2018
• 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
• Patient Age: 24 YR