MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 34CM 125D LEFT; NAIL, FIXATION, BONE

Model Number	71675509
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to a broken compression screw and nail.The patient complained from pain and subsequent x rays showed the broken implants.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.The lab analysis concluded that from the analysis conducted during this investigation, it was concluded that the intertan 10s 10mm x 34cm nail fractured by the initiation and subsequent propagation of tensile forces and torsional shear forces.The fracture likely initiated on the lateral side of the nail through the proximal hole.The shear forces quickly propagated in a quasi-static manner to an extent that the cross-sectional area of the nail could not bear the imposed loading, which led to an overload fracture of the nail.No material deviations were found during this investigation.The clinical/medical evaluation concluded that the single undated x-ray provided confirms the breakage of the intertan nail at the proximal screw hole as well as what appears to be persistent non-union of the femoral neck and lesser trochanter though comparative images were not provided.According to the product evaluation, the breakage area of the nail could not bear the imposed loading, which led to the overload fracture.However, without information regarding the patient¿s medical history, trauma or weight bearing status, the root cause of the breakage cannot be confirmed.The impact to the patient is the patient is the reported pain and the subsequent revision procedure.Should additional medical information be provided this complaint will be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.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 documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: INTERTAN 10S 10MM X 34CM 125D LEFT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10411796
• Report Number: 1020279-2020-03956
• Device Sequence Number: 2552749
• Product Code: JDS
• UDI-Device Identifier: 00885556344149
• UDI-Public: 00885556344149
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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: 05/08/2025
• Device Model Number: 71675509
• Device Catalogue Number: 71675509
• Device Lot Number: 15EM07576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/15/2020
• Supplement Report FDA Received Date: 08/13/2021
• 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: Hospitalization; Required Intervention
• Patient Weight: 70