MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE

Model Number	656318
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported,"in the act of the surgeon blocking the screw on the plate, the screw head broke.".
Event or Problem Description
As reported: "in the act of the surgeon blocking the screw on the plate, the screw head broke.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned, and no other evidences were provided.The event indicates that the screw could not be locked into the plate hole adequately and broke.A non-conformity report (nc) was already initiated based on previous complaints reporting the same event.The nc investigation is not yet concluded.A device inspection was not possible since the affected device was not returned, and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10759490
• Report Number: 0008031020-2020-02371
• Device Sequence Number: 14282364
• Product Code: HWC
• UDI-Device Identifier: 07613327068696
• UDI-Public: 07613327068696
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 656318
• Device Catalogue Number: 656318
• Device Lot Number: 1000325773
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1