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

Model Number 54-25687

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 04/21/2023

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.

Event Description

It was reported that the variax plate broke and the patient reported pain.

Manufacturer Narrative

Please note the corrections to d1, d3, d4 lot #, gtin, d9/h3, h6 method and h6 results codes.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received plate was found to be broken from one of the holes along the axis of the plate.All the four breakage surface showed similar characteristic which is appearance of shiny surface.Presence of shiny surface is indicative of the fact that the plate broke in a fatigue manner due to loading.Shiny surface appears when the plate breaks slowly in a fatigue manner, layer by layer, rubbing one surface over the other.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation it was determined that the plate broke in a fatigue manner possibly due to overloading.Since no patient medical records and other relevant information are unavailable, an exact root cause could not be determined.If any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the variax plate broke and the patient reported pain.

• Brand Name: VOLAR DR PLATE INTERM. RIGHT 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: 16945486
• MDR Text Key: 315372731
• Report Number: 0008031020-2023-00201
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327005509
• UDI-Public: 07613327005509
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 54-25687
• Device Catalogue Number: 54-25687S
• Device Lot Number: 1000507576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2022
• 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