MAUDE Adverse Event Report: STRYKER GMBH VOLAR DR PLATE INTERM. LEFT LONG; PLATE, FIXATION, BONE

Catalog Number	54-25677S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Wound Infection (2447); Implant Pain (4561)
Date of Event	08/17/2023
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 a patient required revision surgery due to breakage of the variax plate and infection from the resulting open wound.Breakage of the device was confirmed on x-ray following progressive pain.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the failure mode reported.The device inspection revealed the following: the plate was returned and is indeed broken in two parts.The analysis of the breakage surfaces shows a fatigue pattern apparent by the shiny surfaces that appear on both sides.This is an indication that the device got broken gradually and that the two sides rubbed against each other for a while before breaking completely.Based on investigation, the root cause was attributed to a fatigue related issue.The exact root cause of what lead to the fatigue could not be determined since more information like the x-rays, patient activity levels and details is required.Some indication of the patient activity levels such as "he used his left hand on the toilet and hear it snap.He didn't fall on it." was given and could lead to believe that an important amount of force was used on the implant sporadically by the patient, but more information is required.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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that a patient required revision surgery due to breakage of the variax plate and infection from the resulting open wound.Breakage of the device was confirmed on x-ray following progressive pain.

• Brand Name: VOLAR DR PLATE INTERM. LEFT LONG
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17780326
• Report Number: 0008031020-2023-00340
• Device Sequence Number: 17861503
• Product Code: HRS
• UDI-Device Identifier: 04546540729521
• UDI-Public: 04546540729521
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K133974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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: 54-25677S
• Device Lot Number: 1000485013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male