MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 40CM 125D LEFT; NAIL, FIXATION, BONE

Model Number	71675515
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation surgery on (b)(6) 2021, a intertan 10s 10mm x 40cm 125d left and a intertan lag/ compression screw kit 95mm / 90mm broke.A revision surgery was performed on (b)(6) 2021 to remove it and insert a new one.Current health status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the breakage was confirmed.The clinical/medical investigation concluded that, per subsequent e-mail, no relevant clinical information will be provided for inclusion in this medical investigation.The intake form provided was reviewed and it was non-contributory.Based on review of the undated, unlabeled x-ray by justin templeton md, a conclusion cannot be made on the root cause of the nail breakage.Therefore, the impact to the patient beyond the reported revision to a new nail cannot be determined.Should any additional relevant clinical information be provided, this complaint 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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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.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 10S 10MM X 40CM 125D LEFT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12453351
• Report Number: 1020279-2021-06790
• Device Sequence Number: 20173452
• Product Code: JDS
• UDI-Device Identifier: 00885556344446
• UDI-Public: 00885556344446
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 71675515
• Device Catalogue Number: 71675515
• Device Lot Number: 20DM03256
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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