MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 18CM 125D; NAIL, FIXATION, BONE

Model Number	71675383
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after the trauma surgery performed on (b)(6) 2021, the intertan 10s 10mm x 18cm 125d broke.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.The lag/comp screw kit 95/90 and the trigen low profile screw 5.0mm x 35mm were also explanted.
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 fractured across the distal slotted through hole.Both pieces were returned.The device is heavily worn at the fracture site.The clinical / medical investigation concluded that, without the requested relevant clinical information, the root cause of the reported breakage cannot be determined.Based on the information provided, a revision surgery was performed approximately a month later.Per the report, during the revision the lag/comp screw kit 95/90 and the trigen low profile screw 5.0mm x 35mm were explanted to treat this adverse event.Per subsequent e-mail, it was reported the patient is doing fine.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant clinical information be provided, this complaint will be re-assessed.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 have no 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 was previously identified.Some potential probable causes for this event could include a traumatic injury, non-union or surgical technique.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: INTERTAN 10S 10MM X 18CM 125D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11909911
• Report Number: 1020279-2021-04870
• Device Sequence Number: 4395361
• Product Code: JDS
• UDI-Device Identifier: 00885556105696
• UDI-Public: 00885556105696
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71675383
• Device Catalogue Number: 71675383
• Device Lot Number: 20KM13695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAG/COM SCREW KIT 110/105/ 20ET37639; LAG/COMP SCREW KIT 95/90/ 20LT43117; TRIGEN LOW PROFILE SCREW 5.0MM X 35MM/UNK
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention