MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM; PLATE, FIXATION, BONE

Model Number	657312S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
When inserting the locking screw (657312s) into the plate ((b)(4)), a thin metal piece was generated.It has been removed and no longer remains in the body.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the screw as well as some metal abrasion / swarf was returned.The damage of the screw thread is clearly visible, the metal abrasion has come of the entire middle section of the screw thread.A close up (taken by the microscope) clearly indicates that the screw had been inserted on an angle from the start, as the metal swarf was getting from thin to thick as the screw was inserted further till the final breakage clearly proves that as well.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 an inadequate applied angle during screw insertion.If any further information is provided, the investigation report will be updated.
Event or Problem Description
When inserting the locking screw (657312s) into the plate (4020903s), a thin metal piece was generated.It has been removed and no longer remains in the body.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9614115
• Report Number: 0008031020-2020-00112
• Device Sequence Number: 14057648
• Product Code: HRS
• UDI-Device Identifier: 07613327086829
• UDI-Public: 07613327086829
• Combination Product (Y/N): N
• 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): 04/01/2020

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 Expiration Date: 09/30/2024
• Device Model Number: 657312S
• Device Catalogue Number: 657312S
• Device Lot Number: D50232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 12/25/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1