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

Model Number	54-25687
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the variax plate broke and the patient reported pain.
Additional 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 or Problem Description
It was reported that the variax plate broke and the patient reported pain.

• Brand Name: VOLAR DR PLATE INTERM. RIGHT 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: 16945486
• Report Number: 0008031020-2023-00201
• Device Sequence Number: 6376157
• Product Code: HRS
• UDI-Device Identifier: 07613327005509
• UDI-Public: 07613327005509
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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: 54-25687
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2022
• 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 Sex: Unknown