MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX40CM 125D RT; NAIL, FIXATION, BONE

Model Number	71676560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Insufficient Information (4580)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after procedure, a revision surgery was performed to remove nail due to a non surgical acute trauma.A competitors device was implanted and the outcome of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no response to clinical requests were not provided nor was the s+n device returned to fully evaluate the root cause of the reported non-surgical acute trauma.Per report, a competitor¿s device was implanted, however, the outcome of the patient is unknown.Therefore, no further clinical/medical assessment is warranted at this time.Should any addition relevant clinical information be provided, this complaint will 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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 11.5MMX40CM 125D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10969624
• Report Number: 1020279-2020-07226
• Device Sequence Number: 910429
• Product Code: JDS
• UDI-Device Identifier: 00885556040225
• UDI-Public: 00885556040225
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 71676560
• Device Catalogue Number: 71676560
• Device Lot Number: 17FT88267
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 07/07/2021
• 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 100/95; TRIGEN LOW PROFILE SCREW 5.0MM X 50MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention