MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM L-D FEM LK PL 8H R 193MM; PLATE, FIXATION, BONE

Model Number	71800108
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery performed on (b)(6) 2021, on (b)(6) 2021 the 4.5mm lat dist femur lck pl 8h r 193mm was repositioned.On (b)(6) 2022 x rays showed that the 4.5mm lat dist femur lck pl 8h r 193mm was fractured and on (b)(6) 2022 the 4.5mm lat dist femur lck pl 8h r 193mm was removed and exchanged.The current health status of the patient is unknown.
Event or Problem Description
It was reported that, after an internal fixation surgery performed on (b)(6) 2021, on (b)(6) 2021 the 4.5mm l-d fem lk pl8h r 193mm was repositioned.On (b)(6) 2022 x rays showed that the 4.5mm l-d fem lk pl8h r 193mm was fractured and on (b)(6) 2022 the 4.5mm l-d fem lk pl8h r 193mm was removed and exchanged.The current health status of the patient is unknown.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be fractured into two components, rendering the device inoperative.Both of the fractured components were returned along with the mating screws.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that based on the limited information provided, the clinical root cause of the surgical repositioning and the subsequent breakage of the device cannot be concluded.The persistent non-healed fracture as well as the patient¿s weight bearing status and subject activity level, which were not provided, cannot be ruled out as contributing factors to the reported events based on the information provided.The patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
B5, d4, h4, updated.

• Brand Name: 4.5MM L-D FEM LK PL 8H R 193MM
• 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: 14605599
• Report Number: 1020279-2022-02757
• Device Sequence Number: 12031510
• Product Code: HRS
• UDI-Device Identifier: 03596010520074
• UDI-Public: 03596010520074
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2022

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: 71800108
• Device Catalogue Number: 71800108
• Device Lot Number: 20EM02017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 07/11/2022; 07/14/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/13/2022; 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PERI-LOC 4.5MM T25 CRTX SCREW 28MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 28MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 30MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 66MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 68MM S-T
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 70 KG