MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DR PLATE, WIDE, SHORT; PLATE, FIXATION, BONE

Model Number	54-25398
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2020
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: "angular stability does not work / screw has not gripped and cannot be screwed out.".
Event or Problem Description
As reported: "angular stability does not work / screw has not gripped and cannot be screwed out.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the screw and plate were returned and analyzed below the microscope.The threads of the locking mechanism below the screw head saw a plastic deformation that could explain the loss of the angular locking.A straight locking of the screw on the plate could however be performed.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 available information, no further action is required at this time.If any further information is provided, the investigation report will be updated.

• Brand Name: VOLAR SMARTLOCK DR PLATE, WIDE, SHORT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10388729
• Report Number: 0008031020-2020-02129
• Device Sequence Number: 17061187
• Product Code: HRS
• UDI-Device Identifier: 07613153068419
• UDI-Public: 07613153068419
• Combination Product (Y/N): N
• PMA/510(K) Number: K040022
• 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): 10/29/2020

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: 54-25398
• Device Catalogue Number: 54-25398
• Device Lot Number: 1000245901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1