MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 10MMX34CM 130D LT; NAIL, FIXATION, BONE

Model Number	71676531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation surgery performed on (b)(6) 2021, the patient experienced pain due to the intertan 1.5 10mmx34cm 130d lt being broken.It is unknown how this will be resolved, as well as the current health status of the patient.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the pictures were reviewed, and the fracture was confirmed.The clinical/medical investigation concluded that, a single undated, undated x-ray photo shows the intertan nail is broken on the left, which supports the complaint.However, smith and nephew has not received the device/adequate clinical documentation to fully evaluate the complaint.Therefore, a thorough medical investigation cannot render, nor could the definitive clinical root cause of the reported failure be determined.The impact to the patient beyond that which has been reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed that weight bearing on bones that have failed to heal or healed partially or improperly can cause stress and fatigue in metallic surgical implants with consequent breakage or failure of the implants.Besides, loosening, bending, cracking or fracture of the implant components have been identified as possible adverse effects.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.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.The contribution of the device to the reported incident could be corroborated as the device was fractured and it was required a revision surgery to treat this event.Based on this investigation, the need for corrective action is not indicated.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 1.5 10MMX34CM 130D LT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14690983
• Report Number: 1020279-2022-02997
• Device Sequence Number: 20127551
• Product Code: JDS
• UDI-Device Identifier: 00885556038024
• UDI-Public: 00885556038024
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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 Expiration Date: 08/04/2024
• Device Model Number: 71676531
• Device Catalogue Number: 71676531
• Device Lot Number: 14HM04294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/12/2022
• Date Device Manufactured: 08/07/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female