MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM LCK COMP PL 14H {} 265MM; PLATE, FIXATION, BONE

Model Number	71829314
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation revision surgery performed on (b)(6) 2021 the patient underwent another revision surgery on (b)(6) 2021 to remove the inserted peri-loc 4.5mm locking compression plate 14 hole 265mm due to fracture.Current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
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.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that the single x-ray provided dated (b)(6) 2021, revealed three months post-revision the 14-hole plate is broken between the 5 and 6 screw holes, as well as a persistent and unstable fracture which would increase the stress on the plate over the three months post-op.However, without comparison of immediate post-implantation and immediate post-revision x-rays we are unable to determine how the fracture was repaired in the primary surgery or in 1st revision surgery.Therefore, the root cause of the reported fracture cannot be definitively determined.Although we cannot rule out the patient¿s age, early weight bearing and the reported history of poly-trauma as likely contributory factors.The impact to the patient was the fracture and the 2nd revision.Should any additional relevant medical information be provided, this case 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.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.The contribution of the device to the reported incident could be corroborated as the device was broken and it was required a revision surgery to treat this event.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.

• Brand Name: 4.5MM LCK COMP PL 14H {} 265MM
• 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: 14742808
• Report Number: 1020279-2022-03037
• Device Sequence Number: 20199930
• Product Code: HRS
• UDI-Device Identifier: 03596010527646
• UDI-Public: 03596010527646
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K033669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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: 71829314
• Device Catalogue Number: 71829314
• Device Lot Number: 19HT26577
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• 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 24MM S-T; PERI-LOC 4.5MM T25 CRTX SCREW 28MM S-T; PERI-LOC 4.5MM T25 CRTX SCREW 34MM S-T; PERI-LOC 4.5MM T25 CRTX SCREW 36MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 30MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 32MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 34MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 36MM S-T; PERI-LOC 4.5MM T25 LOCK SCREW 42MM S-T
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 80 KG