MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 20CM 130D; NAIL, FIXATION, BONE

Catalog Number	71675211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to the patient due to it was found by fluoroscopy that the nail was broken.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, from the analysis conducted during this investigation, it was concluded that the 11.5mm intertan nail fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross-sectional area of the nail could not bear the imposed patient loading, which led to an 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.These excessive cyclic stresses 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.No manufacturing or material deviations were found during this investigation.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the part revealed no prior complaints for the listed batch/failure mode.The clinical/medical team concluded, this complaint was re-opened due to the product return.However, no clinical relevant documents were provided to conduct a thorough medical assessment.Based solely on the product analysis it was concluded the 11.5mm intertan nail fractured by the initiation and subsequent propagation of fatigue cracking.The future impact to the patient beyond the revision cannot be concluded.Therefore, no further clinical/medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.This investigation is closed.

• Brand Name: INTERTAN 11.5MM X 20CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7883440
• Report Number: 1020279-2018-01818
• Device Sequence Number: 2726320
• Product Code: JDS
• UDI-Device Identifier: 03596010565167
• UDI-Public: 03596010565167
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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: 71675211
• Device Lot Number: 17FT88740
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 04/29/2019
• 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