MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX2 5 HOLE / L59MM; PLATE, FIXATION, BONE

Model Number	626675
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Retained by hospital.
Event or Problem Description
It was reported that the patient's left radius was revised 1 month post-op due to a bent plate.The bent radius plate and an ulnar plate were revised.Rep confirmed there are no allegations against the ulnar plate.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned for investigation.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.The instructions for use states: ¿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.The implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular post-operative examinations (e.G.X-ray checks) are advisable.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, one of the probable causes of failure could be patient factor such as incorrect behavior and high level of activity after the implantation.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the patient's left radius was revised 1 month post-op due to a bent plate.The bent radius plate and an ulnar plate were revised.Rep confirmed there are no allegations against the ulnar plate.

• Brand Name: ONE-THIRD TUBULAR PLATE VARIAX2 5 HOLE / L59MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10379524
• Report Number: 0008031020-2020-02086
• Device Sequence Number: 16936070
• Product Code: HRS
• UDI-Device Identifier: 07613327088656
• UDI-Public: 07613327088656
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: 12/31/2023
• Device Model Number: 626675
• Device Catalogue Number: 626675
• Device Lot Number: D13751
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR