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

Model Number	54-25384
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
X-rays showed plate fracture, leading to revision surgery.
Event or Problem Description
X-rays showed plate fracture, leading to revision surgery.
Additional Manufacturer Narrative
Correction: section a2.The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by an off-label use.The x-rays sent were reviewed by stryker's medical expert, his statement is the following: "the patient was initially operated somewhere in february 2019.Apparently the patient went to another hospital for complaints.Looking at the initial x-ray and the post-operative x-ray from october.It is clearly visible that the plate broke at one of the original fracture lines.That means that the pain of the patient must be explained by a non-union of the fracture.[¿] since this fracture had not healed after the initial surgery, it can be considered to be at least a delayed union.However since the plate breakage is at the exact fracture line.It is most probably a non-union.I do not see any callus formation on the second x-ray, which must probably would have been there if some healing had occurred in the fracture.For these revisions surgeries other plates (xxl anatomical volar plates) are intended to be used.So the use of the broken plate (narrow volar plate) can be considered as off-label use." moreover, the operative technique guide mentions that the xxl volar plate should be used in case of non-unions or malunions: "following additional indications apply only for the xxl volar distal radius plates: osteotomies, non-unions, and malunions." therefore, this case is classified as a user related issue.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 ; CH 2545
• MDR Report Key: 9288612
• Report Number: 0008031020-2019-01599
• Device Sequence Number: 2104713
• Product Code: HRS
• UDI-Device Identifier: 07613154345502
• UDI-Public: 07613154345502
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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 Model Number: 54-25384
• Device Catalogue Number: 54-25384
• Device Lot Number: 1000351347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/22/2020
• 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: 44 YR