MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM LCK COMP PL 12H {} 229MM; PLATE, FIXATION, BONE

Model Number	71829312
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery performed on (b)(6) 2021, the patient underwent a revision surgery on 13-aug-2021 to remove the peri-loc 4.5mm locking compression plate 12 hole 229mm due to fracture.Patient underwent another revision surgery on 22-nov-2021 due to another plate breakage.
Additional Manufacturer Narrative
Lot number, manufacturer and expiration dates: updated.
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 is fractured, rendering the device inoperative.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 two-x-ray photos revealed the plate is broken between the 5 and 6 screw holes, as well as an persistent and unstable fracture which would increase the stress on the plate over the two months post-op.However, without comparison x-rays we are unable to determine how the fracture was repaired in the primary surgery.Therefore, the root cause of the reported breakage cannot be definitively determined.Although we cannot rule out early weight bearing and the reported history of poly-trauma as likely contributory factors.The impact to the patient was the revision.Based on the information provided, this patient underwent another revision 3 months later.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 revealed this failure mode was previously identified.A review of the ifu was performed, and the fracture fixation devices reveals in adverse effects that cracking and fracture of the implant components can occur.A special note states that with repeated stress in patients with 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.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.As the device broke and it can no longer fit its purpose, the contribution of the device to the reported event could be corroborated.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, or implant failure.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 12H {} 229MM
• 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: 14610496
• Report Number: 1020279-2022-02759
• Device Sequence Number: 17484488
• Product Code: HRS
• UDI-Device Identifier: 03596010527639
• UDI-Public: 03596010527639
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2022

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: 71829312
• Device Catalogue Number: 71829312
• Device Lot Number: 10KT00323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 07/11/2022; 08/26/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/13/2022; 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2010
• 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: 4.5MM LCK COMP PL 14H {} 265MM; PERI-LOC 4.5MM T25 CRTX SCREW 20MM S-T; PERI-LOC 4.5MM T25 CRTX SCREW 34MM 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 38MM S-T
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 80 KG