MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM M-D TIB LK PL16H L 262MM; PLATE, FIXATION, BONE

Model Number	71801016
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, a tibial osteotomy was performed with plate and screw fixation.2 years after operation, the plate 3.5mm m-d tib lk pl16h l 262mm fractured.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed and the failure mode was confirmed.The clinical/medical investigation concluded that, the single undated, unlabeled x-ray provided reveals the distal portion of the plate is fractured through an unused screw hole, but no bone fracture is appreciated in the provided image.However, without the requested clinical information, pre/post implantation radiographs, trauma history or the device the root cause of the reported fracture cannot be determined.Future medical interventions for the patient are unknown at this time.Therefore, the impact to the patient beyond that which has already been reported is unknown.Should any additional medical information be provided, this complaint would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 3.5MM M-D TIB LK PL16H L 262MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11922378
• Report Number: 1020279-2021-04961
• Device Sequence Number: 14269946
• Product Code: HRS
• UDI-Device Identifier: 03596010520630
• UDI-Public: 03596010520630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: Health Professional
• Device Expiration Date: 05/09/2016
• Device Model Number: 71801016
• Device Catalogue Number: 71801016
• Device Lot Number: 11EM06545
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 19 YR