MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX 2 ONE-THIRD TUBULAR 12 HOLE / L143MM; PLATE, FIXATION, BONE

Catalog Number	626682
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	06/27/2024
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
As reported: "during revision due to pseudarthrosis the surgeon discovered a broken plate.The plate was replaced.".
Event or Problem Description
As reported: "during revision due to pseudarthrosis the surgeon discovered a broken plate.The plate was replaced." additional information received: the patient felt a sharp pain after carrying a load.
Additional Manufacturer Narrative
Correction: please refer to section d6a.The reported event could be confirmed, since the device was returned broken as reported.The device inspection revealed the following: as received condition, the plate is broken apart between the sixth and seventh holes.No other devices, such as screws, were returned.The fracture resembles a fatigue fracture with uniform fine-grained texture over almost the complete surface.The breakage most likely started on the right side, where the shiny surfaces indicate that the fragments rubbed against each other during the crack progress before the plate broke apart.Furthermore, relevant dimensions were verified during the investigation and no deviation from the specification was detected.Following the above device inspection, no product related issue could be detected.It was however reported that the patient suffered from pseudarthrosis and that the broken plate was discovered because patient felt a sharp pain after carrying a load.Therefore, it is likely that the root cause of the event was a patient-related issue, due to the patient pseudarthrosis condition.It is important to note that since there was no additional information provided (x-rays, operation reports.), the root cause can only be assumed from the reported information and cannot be confirmed.In this relation, the following statements from the variax 2 one-third tubular instructions for use can be pointed out: post-operative patient activity: these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation.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.

• Brand Name: ONE-THIRD TUBULAR PLATE VARIAX 2 ONE-THIRD TUBULAR 12 HOLE / L143MM
• 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: 19818914
• Report Number: 0008031020-2024-00276
• Device Sequence Number: 15630529
• Product Code: HRS
• UDI-Device Identifier: 07613327088533
• UDI-Public: (01)07613327088533(10)H64236
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 626682
• Device Lot Number: H64236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 56 KG