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

Catalog Number 54-25386

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Device not yet evaluated.When additional information becomes available it will be provided on a supplemental report.

Event Description

Screw was not angularly stable and spun.Replacement was available.

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 Description

Screw was not angularly stable and spun.Replacement was available.

• Brand Name: VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, RIGHT,SHORT, 11 HOLES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7601967
• MDR Text Key: 111868181
• Report Number: 0008031020-2018-00464
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613154345526
• UDI-Public: 07613154345526
• Combination Product (y/n): N
• PMA/PMN Number: K040022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 54-25386
• Device Lot Number: 1000288669
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other