MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX2 6 HOLE / L71MM; PLATE, FIXATION, BONE

Catalog Number	626676
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	11/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed (looking at the x-rays and pictures provided by the customer).Product will not be returned for evaluation (retained by patient) and no additional information is available.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.Original statement from stryker medical expert: "in ulna fractures, relatively high shear forces occur due to the rotational movements, which must be absorbed by the plate.In some fractures i used 4.5mm plates, when there were additional negative aspects regarding the healing potential of the patient (e.G.Diabetes).Good clinical practice would recommend, that you have six cortices on both sides of the fracture reached by the plate.In this case it is only true for the proximal part.It would have been a good idea to choose a 7 hole-plate.Summarized i think that a stronger plate should have been taken in the first place-especially because a reduced healing potential could have been expected in a diabetic patient.If one chooses a smaller plate it would have been recommendable to take a 7 hole plate to ensure secure fixation." 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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
1/3rd tubular plate broke at a screw hole.Patient went in for a normal post op check up on 11/22 and it was noticed on x ray that the plate started to crack.The following day 11/23 the patient went back to the doctors office because she was in severe pain on her elbow where the implant was put.Device was explanted.

• Brand Name: ONE-THIRD TUBULAR PLATE VARIAX2 6 HOLE / L71MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9508131
• Report Number: 0008031020-2019-02308
• Device Sequence Number: 19575000
• Product Code: HRS
• UDI-Device Identifier: 07613327088724
• UDI-Public: 07613327088724
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2019

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: 09/30/2023
• Device Catalogue Number: 626676
• Device Lot Number: Y49237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/21/2019
• 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: 67 YR
• Patient Weight: 51