MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES; PLATE, FIXATION, BONE

Model Number	54-25384
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2020
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
Pharmacist reported to stryker that: "during a procedure, it was impossible to insert one of the locked screws into one of the holes in the plate, which prevented the plate from being fixed.The existing screws and the plate were removed in order to install a new plate.Clinical consequences : nothing to report.Action taken: device quarantined, awaiting retrieval and expertise".
Event or Problem Description
Pharmacist reported to stryker that: "during a procedure, it was impossible to insert one of the locked screws into one of the holes in the plate, which prevented the plate from being fixed.The existing screws and the plate were removed in order to install a new plate.Clinical consequences : nothing to report.Action taken: device quarantined, awaiting retrieval and expertise".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the plate was returned and doesn't show any extensive signs of usage.The screw holes in this plate show a little abrasion of metal due to the screw insertion reported.The plate was tested with a random variax 2 locking screw, which locked perfectly.The plate is therefore considered functional.An nc was opened and is investigating the event further, from a screw perspective.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.If any further information is provided, the investigation report will be updated.

• Brand Name: VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10673048
• Report Number: 0008031020-2020-02324
• Device Sequence Number: 14093765
• Product Code: HRS
• UDI-Device Identifier: 07613154345502
• UDI-Public: 07613154345502
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 54-25384
• Device Catalogue Number: 54-25384
• Device Lot Number: 1000418880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1