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

Model Number	54-25392
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported the variax2 dr plate was bent.Revision of the patient was performed.
Event or Problem Description
It was reported the variax2 dr plate was bent.Revision of the patient was performed.
Additional Manufacturer Narrative
The reported event could be confirmed, since the post-operative deformation of the plate is visible on the received x-rays.The device inspection revealed the following: the visual inspection has shown that the plate is deformed between the 5th and the 6th hole.The received x-ray shows that this deformation occurred post-operative.There are also other deformations visible, the area of the oblong hole is slightly deformed and the head piece is bent downward, most likely caused during contouring.Because there are some dents at the plate surface visible that indicate intra-operative contouring of the plate.A dimensional inspection was performed and no deviation from the specification could be detected.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.Based on investigation, the root cause was attributed to a patient related issue.The complaint has been reviewed by an medical expert with following result: "usually the stress should be reduced to normal movement without force (or limitation up to 1-2 kilograms) till consolidation is achieved.The deformation is only plausible with a second trauma like a new fall or a really high extension force." if more information is provided, the case will be reassessed.

• Brand Name: VOLAR SMARTLOCK DR PLATE,STANDARD,X-LONG
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12150150
• Report Number: 0008031020-2021-00299
• Device Sequence Number: 17072113
• Product Code: HRS
• UDI-Device Identifier: 07613154379507
• UDI-Public: 07613154379507
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 54-25392
• Device Catalogue Number: 54-25392
• Device Lot Number: 1000206394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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: 79 YR