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

Catalog Number	54-25384
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device is not available to stryker.
Event or Problem Description
As reported in ethics hotline case number (b)(4): "on (b)(6) 2018, at least one screw and one plate malfunctioned while a surgeon was trying to put in a walking peg.The procedure was done correctly, but when the screw was used it only spun and could not engage.A second screw, however, did engage successfully".Rep verbally reported a 10 min surgical delay, no adverse consequences to the patient.Primary procedure.
Additional Manufacturer Narrative
The reported event that volar smartlock distal radius plate, narrow, right,short, 9 holes was alleged of 'no locking effect' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported in ethics hotline case number (b)(4): "on (b)(6) 2018, at least one screw and one plate malfunctioned while a surgeon was trying to put in a walking peg.The procedure was done correctly, but when the screw was used it only spun and could not engage.A second screw, however, did engage successfully".Rep verbally reported a 10 min surgical delay, no adverse consequences to the patient.Primary procedure.".

• 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 ; CH 2545
• MDR Report Key: 7600641
• Report Number: 0008031020-2018-00462
• Device Sequence Number: 16660704
• Product Code: HRS
• UDI-Device Identifier: 07613154345502
• UDI-Public: 07613154345502
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K040022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: 54-25384
• Device Lot Number: 1000227718
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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