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

Model Number	71676579
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was admitted in hospital with pain.On x-ray surgeon found that implant used for intertrochanteric fracture has broken.A revision surgery was performed due to this incident.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A lab analysis was conducted and confirms that the intertan nail fractured by the initiation and subsequent propagation of fatigue cracking.The cracking propagated to an extent that the remaining cross-sectional area of the nail could not bear the imposed patient loading, leading to overload fracture.Fatigue cracking is caused by the nail bearing cyclic (i.E.Repeated) stresses in excess of the material endurance limit for an extended period of time; may be caused by any number of conditions, including but not limited to excessive patient activity levels prior to full bone union, applications of loads in excess of the material¿s strength, and/or poor bone quality.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history on the listed part revealed no prior complaints for the listed batch.A clinical evaluation was conducted that an unrelated fall caused the reported neck fracture and broken nail, confirmed by the x-ray.Based on the information provided the broken nail was due to a twisting injury sustained by the patient and not a mal-performance of the implant.The future impact to the patient cannot be determined.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, as traumatic injury and overuse.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We will continue to monitor for future complaints and investigate as necessary.

• Brand Name: INTERTAN 1.5 11.5MMX38CM 130D LT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8834701
• Report Number: 1020279-2019-02815
• Device Sequence Number: 19656816
• Product Code: JDS
• UDI-Device Identifier: 00885556039830
• UDI-Public: 00885556039830
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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 Expiration Date: 02/21/2026
• Device Model Number: 71676579
• Device Catalogue Number: 71676579
• Device Lot Number: 16BM17572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/28/2019
• Supplement Report FDA Received Date: 03/03/2020
• 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