MAUDE Adverse Event Report: STRYKER GMBH DISTAL MEDIAL TIBIA PLATE AXSOS 3 TI FOR RIGHT TIBIA 14 HOLE / L227MM; PLATE, FIXATION, BONE

Model Number	627444S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/25/2020
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.: device discarded.
Event or Problem Description
It was reported: the plate was found to have broken 3 months after the operation.The doctor thinks that the broken part has some load and is broken.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned, and no other evidence was provided.The removed implant was accidentally discarded at the hospital.A device inspection was not possible since the affected device was not returned, and no other evidence was provided 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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event such as the patient's details, his activity level post op, x-rays, mobilization instructions of surgeon and its compliance by patient, as well as the affected device must be available in order to determine the root cause of the complaint event.In general, one of the probable root causes of plate breakage is patient related (excess loading and weight bearing).Ifu also states ¿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.¿ conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ improper alignment can cause a mal-union of the bone and/or bending, cracking or even breakage of the device.¿ if the device is returned or any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported: the plate was found to have broken 3 months after the operation.The doctor thinks that the broken part has some load and is broken.

• Brand Name: DISTAL MEDIAL TIBIA PLATE AXSOS 3 TI FOR RIGHT TIBIA 14 HOLE / L227MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10176355
• Report Number: 0008031020-2020-01708
• Device Sequence Number: 14109699
• Product Code: HRS
• UDI-Device Identifier: 07613327082692
• UDI-Public: 07613327082692
• Combination Product (Y/N): N
• PMA/510(K) Number: K181091
• 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): 08/19/2020

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: 02/29/2024
• Device Model Number: 627444S
• Device Catalogue Number: 627444S
• Device Lot Number: Y56795
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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: 38 YR
• Patient Weight: 73