MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX2 7 HOLE / L83MM; PLATE, FIXATION, BONE

Model Number	626677S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348); Implant Pain (4561)
Date of Event	06/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported: on (b)(6), the product was fixed with a fracture of the proximal ulna.The patient resumed daily activities a few days after surgery.On (b)(6) the patient complained of pain.When i took an x-ray, the plate was broken.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the device was returned, and is indeed broken at the level of the 4th locking hole.The surface of the breakage shows typical traces of a fatigue fracture: shiny surfaces on both bridges prove that the plate broke partially first, causing the two sides of the plate to rub against each other.The cracks of the material propagated with the mechanical loading, before the material gave in completely.Since an x-ray was provided, a clinical statement was requested for the evaluation of the provided medical data.The following statements were provided: "[.] from a personal/surgical point of view i would most probably not have used a 1/3 tubular plate for a proximal ulnar fracture.The forces on this bone are too big, especially if the patient started to take up daily activities.Personally i would have chosen a straight compression plate.These plates are much stronger and can withstand the forces from the muscles overarching the elbow joint.So the root cause in the breakage might lie in the fact that the chosen plate was not suitable for this type of fracture, especially not combined with the after care.[.]" therefore, the root cause can be attributed to both the user and the patient.It was due to an inadequate choice of the implant considering the aftercare expectations.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 any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported: on (b)(6) , the product was fixed with a fracture of the proximal ulna.The patient resumed daily activities a few days after surgery.On(b)(6) , the patient complained of pain.When i took an x-ray, the plate was broken.

• Brand Name: ONE-THIRD TUBULAR PLATE VARIAX2 7 HOLE / L83MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10332180
• Report Number: 0008031020-2020-01971
• Device Sequence Number: 825958
• Product Code: HRS
• UDI-Device Identifier: 07613327088762
• UDI-Public: 07613327088762
• Combination Product (Y/N): N
• 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): 09/22/2020

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: 10/31/2023
• Device Model Number: 626677S
• Device Catalogue Number: 626677S
• Device Lot Number: Y50577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/22/2020
• 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