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	10/22/2020
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: "a patient who had implanted the palate before, twisted his/her hand, complained of pain.Confirming that the plate was broken, the broken plated was replaced with a compression plate on (b)(6) 2020.".
Event or Problem Description
As reported: "a patient who had implanted the palate before, twisted his/her hand, complained of pain.Confirming that the plate was broken, the broken plated was replaced with a compression plate on (b)(6) 2020.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received plate was found to be broken at the center hole position.The fracture analysis represents shiny surface, which is generally a sign of fatigue fracture, when the device gradually breaks from one side and rubs against each other due to high repeated cyclic loading.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.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by patient activity, high load on the device.Which is also clear from the statement that the patient twisted their hand.Strenuous load activity on the load sharing device eventually resulted in fatigue fracture.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 further information is provided, the complaint report will be updated.

• 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: 10855885
• Report Number: 0008031020-2020-02482
• Device Sequence Number: 19059941
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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: 01/31/2024
• Device Model Number: 626677S
• Device Catalogue Number: 626677S
• Device Lot Number: D18607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 01/15/2021
• 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