MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 18CM 130D; NAIL, FIXATION, BONE

Model Number	71675208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when checking under x-rays, the doctor understood that he could place an 11.5mm wide nail, but after starting the surgery and trying to place it and re-drill the bone several times, he could not place it and decided to change to a 10mm nail.No information about the patient status was initially provided.
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, per complaint details, while using x-ray, the surgeon made several unsuccessful attempt to place an 11-5mm wide nail, the surgeon made a change in procedure by using a 10mm nail to complete the procedure.Since no other information will be provided, no further clinical/medical, assessment is warranted at this time.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 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 a fit/ sizing issue or poor insertion technique.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 11.5MM X 18CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10637823
• Report Number: 1020279-2020-05176
• Device Sequence Number: 3004550
• Product Code: JDS
• UDI-Device Identifier: 03596010560872
• UDI-Public: 03596010560872
• Combination Product (Y/N): N
• 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): 07/01/2021

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: 71675208
• Device Catalogue Number: 71675208
• Device Lot Number: 20CT36178
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 07/01/2021
• 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