MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, RIGHT,SHORT, 11 HOLES; PLATE, FIXATION, BONE

Catalog Number	54-25386
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet evaluated.When additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
Screw was not angularly stable and spun.Replacement was available.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
Screw was not angularly stable and spun.Replacement was available.

• Brand Name: VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, RIGHT,SHORT, 11 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7601967
• Report Number: 0008031020-2018-00464
• Device Sequence Number: 2142142
• Product Code: HRS
• UDI-Device Identifier: 07613154345526
• UDI-Public: 07613154345526
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 54-25386
• Device Lot Number: 1000288669
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other