MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM; SCREW, FIXATION, BONE

Model Number	657316
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2019
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 by a customer "during the intervention, a metal part separated from the thread of the variax screw.The metal part and the screw were kept but not decontaminated.The surgeon was able to retrieve the metal part that had disengaged from the screw.Metal part and screws put in a pot.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the locking mechanism / thread of the returned locking screw is indeed completely damaged, most of the thread has been torqued / thorn / broken off.A close up views done by the microscope indicating that the screw head t10 drive is still intact.This gives us an indication that the screw must have been forced / inserted on a too steep angle which resulted in the separation of the first two windings of the locking thread.It can be concluded that inappropriate positioning during screw insertion (on a too steep angle) has caused these damages / abrasions.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.Based on investigation, the root cause was attributed to be user related.The failure was caused by inappropriate positioning during screw insertion (on a too steep angle).If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported by a customer "during the intervention, a metal part separated from the thread of the variax screw.The metal part and the screw were kept but not decontaminated.The surgeon was able to retrieve the metal part that had disengaged from the screw.Metal part and screws put in a pot.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9490932
• Report Number: 0008031020-2019-02288
• Device Sequence Number: 11282577
• Product Code: HWC
• UDI-Device Identifier: 07613327086874
• UDI-Public: 07613327086874
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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 Model Number: 657316
• Device Catalogue Number: 657316
• Device Lot Number: L46157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1