MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 24CM 130D; NAIL, FIXATION, BONE

Model Number	71934480
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a trauma surgery in which an intertan 10mm x 24cm 130d nail had been implanted, such nail broke below the compression screw.A revision surgery was perform to explant it.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.Returned devices are broken nail, nail extractor, lag/comp screw kit and low profile screw.A visual inspection of the returned parts shows the intertan nail was broken in 2 pieces by the screw holes.The nail extractor is stuck inside the broken piece and two metal rods are stuck in the other piece of the nail.The clinical/medical evaluation concluded that per report, a revision was performed to remove a broken intertan nail that broke below the compression screw.Per subsequent e-mail, it was reported no relevant clinical information will be provided.Two photos of the broken devices were provided, along with the product evaluation which confirmed the reported failure.However, the root cause of the reported breakage cannot be determined.Therefore, the impact to the patient beyond that which has already be reported cannot be determined.Should any additional medical 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 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.Some potential causes of the reported event could include but are 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 for future complaints and investigate as necessary.

• Brand Name: INTERTAN 10MM X 24CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10285364
• Report Number: 1020279-2020-03281
• Device Sequence Number: 515763
• Product Code: JDS
• UDI-Device Identifier: 00885556105146
• UDI-Public: 00885556105146
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 71934480
• Device Catalogue Number: 71934480
• Device Lot Number: 20AM07098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 07/21/2021
• 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/COMP SCREW KIT 95/90 (71677095); TRIGEN LOW PROFILE SCREW 5.0MM X 35MM (71645035); LAG/COMP SCREW KIT 95/90 (71677095); TRIGEN LOW PROFILE SCREW 5.0MM X 35MM (71645035)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention