MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DR PLATE,NARROW,X-LONG; PLATE, FIXATION, BONE

Catalog Number	54-25391
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient underwent orif distal radius on (b)(6)2018 with variax distal radius system.Cast was removed in (b)(6) 2018.It was reported that the patient allegedly heard a "pop" a few weeks later.Patient was booked for removal of broken hardware and revision orif distal radius with synthes plating system on (b)(6) 2018.
Additional Manufacturer Narrative
The reported event that volar smartlock dr plate, narrow, x-long was alleged implant breakage after surgery could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Device inspection revealed the following, the plate was completely broken in two parts.Both the broken parts were received for evaluation.Close-up views (done by microscope) of the breakage surfaces clearly shows signs of mechanical overload due to nonunion.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by a mechanical overload.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that the patient underwent orif distal radius on (b)(6)2018 with variax distal radius system.Cast was removed in may 2018.It was reported that the patient allegedly heard a "pop" a few weeks later.Patient was booked for removal of broken hardware and revision orif distal radius with synthes plating system on (b)(6)2018.

• Brand Name: VOLAR SMARTLOCK DR PLATE,NARROW,X-LONG
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7682476
• Report Number: 0008031020-2018-00498
• Device Sequence Number: 16314592
• Product Code: HRS
• UDI-Device Identifier: 07613154379491
• UDI-Public: 07613154379491
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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: 54-25391
• Device Lot Number: 1000176931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 10/31/2018
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 72