MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L24MM; PLATE, FIXATION, BONE

Model Number	657324S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2020
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
As reported: "the hexlobular internal was not made on screw head and the screw could not be used.The new one was used for the procedure.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device was returned, and indeed, the torx connection on the screw head was not properly manufactured, making the device unusable.A review of the device history for the reported lot did not indicate any abnormalities.Based on investigation, the root cause was attributed to be manufacturing related.A nonconformity report has been opened in order to further investigate and address this issue for further details.
Event or Problem Description
As reported: "the hexlobular internal was not made on screw head and the screw could not be used.The new one was used for the procedure.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L24MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10417414
• Report Number: 0008031020-2020-02167
• Device Sequence Number: 2670135
• Product Code: HRS
• UDI-Device Identifier: 07613327086997
• UDI-Public: 07613327086997
• 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): 10/12/2020

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: 01/31/2024
• Device Model Number: 657324S
• Device Catalogue Number: 657324S
• Device Lot Number: D14130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1