MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 38CM 130D RIGHT; NAIL, FIXATION, BONE

Model Number	71675536
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Hip Fracture (2349)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a hip fracture a year ago, and an intertan 10s 10mm x 38cm 130d right was implanted.Last oct, 15th, the nail was removed because the fracture never healed and a thr was performed instead.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant clinical information will be provided for inclusion in this medical investigation.Therefore, a thorough medical investigation cannot be rendered.Should any additional relevant clinical information be provided this complaint will be re-assessed.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 10S 10MM X 38CM 130D RIGHT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10814850
• Report Number: 1020279-2020-06332
• Device Sequence Number: 13921296
• Product Code: JDS
• UDI-Device Identifier: 00885556345498
• UDI-Public: 00885556345498
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 71675536
• Device Catalogue Number: 71675536
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 07/23/2021
• 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