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

Catalog Number 54-25677S

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Post Traumatic Wound Infection (2447); Implant Pain (4561)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 323824971
• Report Number: 0008031020-2023-00340
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540729521
• UDI-Public: 04546540729521
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K133974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male