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); Implant Pain (4561)
Date of Event	08/19/2020
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
As reported: "(b)(6) 2020 first surgery.He complained of pain after the operation and visited the hospital on (b)(6).The plate was broken at the screw near the fracture.Patient activity was high.Doctor's view: "i don't know why it breaks."".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the received plate was found to be broken from one of the holes.Upon closer examination, the fracture surface exhibited shiny surface which is generally a sign of fatigue fracture, when the device gradually breaks from one side and rub against each other due to high repeated cyclic loading.Evidence of high loading can also be seen around the hole from where the plate broke, screw bearing marks are present there.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.No patient details, medical records were provided, but only a single plane post-operative (post breakage) x-ray was shared which wasn¿t sufficient.Therefore, a clinical opinion from our hcp could not be requested.However, through that x-ray it was possible ascertain that the fracture had not healed adequately and around that location only the plate had broken.Based on the above investigation and the facts available, it could be said that the root cause of the failure is predominantly patient related.The manner of breakage and through the x-ray provided it can be said that due to the inadequate healing within a span of 2 months, the load increased on the plate around the fracture region.Ultimately, leading to its breakage in a gradual manner.The ifu clearly provides a warning that: ¿these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.¿ if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: (b)(6) 2020 first surgery.He complained of pain after the operation and visited the hospital on (b)(6).The plate was broken at the screw near the fracture.Patient activity was high.Doctor's view: "i don't know why it breaks.".

• 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: 10542442
• Report Number: 0008031020-2020-02243
• Device Sequence Number: 10905427
• 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: 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): 11/17/2020

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: 01/31/2025
• Device Model Number: 626677S
• Device Catalogue Number: 626677S
• Device Lot Number: G16597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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