MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 24CM 125D; NAIL, FIXATION, BONE

Model Number	71934479
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery was performed on an unspecified date, an intertan 10mm x 24cm 125d broke off.On (b)(6) 2021 the patient underwent a revision surgery to remove the broken nail and a synthes compression plate was implanted instead.Patient outcome remains unknown.Clinical information not available.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was fractured into two pieces, rendering the device inoperative.Both of the fractured pieces were returned.The device also has numerous scratches likely from extraction.The clinical/medical evaluation concluded that the responses to clinical requests were not provided, therefore, s+n has not received the adequate documentation to fully evaluate the root cause of the reported event.Based on the limited information provided, the patient was revised to remove the broken nail and a synthes compression plate was implanted instead.The patient impact beyond the reported event could not be determined based on the limited information provided.Therefore, no further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.

• Brand Name: INTERTAN 10MM X 24CM 125D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12526502
• Report Number: 1020279-2021-07129
• Device Sequence Number: 5723610
• Product Code: JDS
• UDI-Device Identifier: 00885556105092
• UDI-Public: 00885556105092
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71934479
• Device Catalogue Number: 71934479
• Device Lot Number: 20GM18267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/19/2021
• 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
• Patient Age: 74 YR