MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX38CM 130D LT; NAIL, FIXATION, BONE

Model Number	71676579
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation had been performed on (b)(6) 2020, on post op x-ray, shows the screws backing out, despite being locked in the case.A revision surgery was performed.Current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.The clinical/medical investigation concluded that, this case reports that following implantation of the intertan system a revision surgery was performed due to the screws backing out despite being locked in the case.The date of the revision surgery was not provided.X-ray photo examples were provided via e-mail; these x-ray images are not directly from this case, but encompass the issue observed in other similar complaint cases that have been already lodged.The x-ray examples provided demonstrate the lag screw and compression screw have backed out.The current health of the patient is unknown.Based on the limited information provided the clinical root cause of the report issue could not be determined.The provided example images were reviewed and confirm the reported however, they are examples from multiple subjects, so a specific root cause could not be concluded.The initial placement of the lag and compression screws within the femoral head, reduction and stability of the fracture, or user technique and cannot be ruled out as contributing factors of the reported screws backing out.The patient impact beyond the report revision could not be determined.No further clinical/medical 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.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.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: INTERTAN 1.5 11.5MMX38CM 130D LT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12396114
• Report Number: 1020279-2021-06638
• Device Sequence Number: 3673284
• Product Code: JDS
• UDI-Device Identifier: 00885556039830
• UDI-Public: 00885556039830
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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 Expiration Date: 06/11/2023
• Device Model Number: 71676579
• Device Catalogue Number: 71676579
• Device Lot Number: 11MM09812A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention