MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM M-D TIB LK PL13H L 223MM; PLATE, FIXATION, BONE

Model Number	71801013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a fracture fixation performed in the month of (b)(6) 2022 utilizing a 3.5mm m-d tib lk pl13h l 223mm, the device broke.At this point, it is unknown if the patient experience any trauma prior the onset of the symptoms, and also, it is unknown if this problem will be intervened; therefore, it is unknown whether a revision surgery will be performed.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Based on a review of the information provided, we are unable to determine the patient¿s impact since it is unknown if the revision surgery has performed.Should any additional relevant medical information be provided, this case would be re-assessed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for fracture fixation devices reveals in adverse effects that cracking and fracture of the implant components can occur with repeated stress in patients, delayed healing or nonunion, the appliance will inevitably bend, break or pull out of bone.Also, according to warnings, the correct selection of device components is extremely important.The appropriate type and size should be selected for the patient.Failure to use the largest possible components or improper positioning may result in loosening, bending, cracking, or fracture of the device or bone or both.Additionally, the precautions section reveals that postoperative instructions to patients and appropriate nursing care are critical.Early weight bearing substantially increases implant loading and increases the risk of loosening, bending or breaking the device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.Additionally, material specification document control the quality and manufacture of the materials used in the production of the device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, size selected, surgical technique or postoperative care.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 PL13H L 223MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15875048
• Report Number: 1020279-2022-04846
• Device Sequence Number: 2531959
• Product Code: HRS
• UDI-Device Identifier: 03596010520623
• UDI-Public: 03596010520623
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2022

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 Model Number: 71801013
• Device Catalogue Number: 71801013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male