MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 20CM 130D; NAIL, FIXATION, BONE

Model Number	71675386
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, about one month after a trauma surgery in which an intertan 10s 10mm x 20cm 130d nail had been implanted, it was discovered that the nail had broken at the distal locking hole.No fall has been associated to the injury, the patient underwent revision surgery to correct the issue.It is unknown the current health status of the patient.
Additional Manufacturer Narrative
Results of investigation: it was reported that the patient underwent intertan surgery and about a month later reported to the clinic where it was discovered that the nail had broken at the distal locking hole.No fall associated to the injury, the patient underwent revision surgery to correct the issue.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the nail has broken in 2 pieces.The broken piece has returned.Scratches are observed on the screws, probably from explantation.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident is corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A medical analysis noted that the provided images confirm the nail breakage and significantly displaced/comminuted femoral fracture along with the lesser and subtrochanteric fractures.It was communicated that no further medical documentation would be provided for inclusion in the medical assessment.Based solely on the images provided, the short length of the nail and possibly excessive weight-bearing cannot be ruled out as contributing factors to the reported event, as trauma was reportedly denied.However, post-implantation images were not provided for comparison; therefore, an adequate primary reduction could not be confirmed.The patient impact beyond the reported event and subsequent revision could not be determined.No further medical assessment can be rendered at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: INTERTAN 10S 10MM X 20CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10399893
• Report Number: 1020279-2020-03902
• Device Sequence Number: 11452525
• Product Code: JDS
• UDI-Device Identifier: 00885556343692
• UDI-Public: 00885556343692
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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 Model Number: 71675386
• Device Catalogue Number: 71675386
• Device Lot Number: 20DM01459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 03/18/2021
• 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