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

Model Number	71829314
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
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 had been performed on (b)(6) 2021, the patient experienced a break.This adverse event was addressed by revision surgery on (b)(6) 2022 to exchange the 4.5mm lck comp pl 14h 265mm.Current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: 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 in half, rendering the device inoperable.Both of the fractured components were returned along with the 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 the revision operative report, x-ray, and photo of the explant confirm the breakage of the compression plate.However, based on the limited information provided, the clinical root cause of the reported event cannot be concluded.The weight bearing status and subject activity level were not provided but cannot be ruled out as a contributing factor based on the information provided.The patient impact beyond the revision cannot 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.

• 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: 14068177
• Report Number: 1020279-2022-01702
• Device Sequence Number: 4923274
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2022

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: 03/17/2022
• Supplement Date Received by Manufacturer: 03/17/2022; 07/08/2022
• Initial Report FDA Received Date: 04/09/2022
• Supplement Report FDA Received Date: 06/08/2022; 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• 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 30MM S-T: 73826030; PERI-LOC 4.5MM T25 CRTX SCREW 32MM S-T: 73826032; PERI-LOC 4.5MM T25 CRTX SCREW 36MM S-T: 73826036; PERI-LOC 4.5MM T25 LOCK SCREW 28MM S-T: 73827028; PERI-LOC 4.5MM T25 LOCK SCREW 30MM S-T: 73827030; PERI-LOC 4.5MM T25 LOCK SCREW 32MM S-T: 73827032; PERI-LOC 4.5MM T25 LOCK SCREW 34MM S-T: 73827034; PERI-LOC 4.5MM T25 LOCK SCREW 36MM S-T: 73827036
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 105 KG