MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX38CM 125D RT; NAIL, FIXATION, BONE

Catalog Number	71676558
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the nail was broken due to a non union of fracture, and the distal screw was also broken for which a proximal femoral replacement and total knee replacement was carried out.The surgeon does not blame the product for the failure.
Additional Manufacturer Narrative
It was reported that a nail was broken due to a non union of fracture and the distal screw was also broken.The associated trigen intertan subtrochanteric lag screw and trigen low profile screw were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.It was reported that the surgeon does not blame the product for the failure.No clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.However, it was reported that the revision was due to a broken nail secondary to bony ¿non-union¿, which is not a component failure.The patient impact beyond the reported non-union and revision procedure could not be determined.Without the return of the actual product involved and no patient records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
The associated trigen intertan nail, trigen intertan subtroch lag screw and trigen low profile screw were not returned for evaluation.Therefore, no product analysis could be performed.However, device details were provided.Thus, our investigation including the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batches which did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode 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.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.No further medical assessment can be rendered at this time.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported broken nail and revision procedure cannot be determined.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: INTERTAN 1.5 11.5MMX38CM 125D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8624638
• Report Number: 1020279-2019-01980
• Device Sequence Number: 2292586
• Product Code: JDS
• UDI-Device Identifier: 00885556039311
• UDI-Public: 00885556039311
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 11/07/2019

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: Health Professional
• Device Catalogue Number: 71676558
• Device Lot Number: 18AT97003
• Initial Date Received by Manufacturer: 04/27/2019
• Supplement Date Received by Manufacturer: 04/27/2019; 04/27/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 08/20/2019; 11/07/2019
• 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 Age: 62 YR