MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX 2 ONE-THIRD TUBULAR 7 HOLE / L83MM; PLATE, FIXATION, BONE

Model Number	626677S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a few day after the surgery the plate fractured.The fractured plate was removed and replaced with two plates.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the plate is broken apart as reported.The device inspection revealed the following: the visual inspection has shown that the plate is broken apart between the forth and third hole.The microscopic evaluation shows that the fracture face has the typical view of a fatigue fracture with uniform fine-grained texture over almost the complete surface.The breakage started on the right side, where the shiny surfaces indicate that the fragments rubbed against each other during the crack progress before the plate completely broke apart.The relevant dimensions were verified during the investigation 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.The plate was returned for evaluation and no product related issue could be detected.There was no additional information, such as x-rays, operation reports, patient history or activity, provided.Therefore the root cause of the breakage cannot be defined.The evaluation of the plate has shown that the implant could not resist the applied force which finally led to the material overload / fatigue failure of the device.In this relation following statements of the variax 2 one-third tubular instructions for use can be pointed out: ¿always exercise care in selecting the proper type and size of implant.Improper selection, placement and fixation of the implant components may result in early implant failure.Implants can be available in different versions, varying for example in length, diameter, angle, right-hand and left-hand versions, material and number of drilled holes.The correct selection of the fracture fixation appliance is extremely important.Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure.Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, cracking or fracture of the device and/or bone.The correct implant size for a given patient can be determined by evaluating the patient¿s height, weight, functional demands and anatomy.Every implant must be used in the correct anatomic location, consistent with accepted standards of internal fixation." if more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that a few day after the surgery the plate fractured.The fractured plate was removed and replaced with two plates.

• Brand Name: ONE-THIRD TUBULAR PLATE VARIAX 2 ONE-THIRD TUBULAR 7 HOLE / L83MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15797400
• Report Number: 0008031020-2022-00612
• Device Sequence Number: 20031418
• Product Code: HRS
• UDI-Device Identifier: 07613327088762
• UDI-Public: 07613327088762
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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 Expiration Date: 05/31/2026
• Device Model Number: 626677S
• Device Catalogue Number: 626677S
• Device Lot Number: H40049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2021
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 65 KG