MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 26CM 125D LEFT; NAIL, FIXATION, BONE

Model Number	71675501
Medical Device Problem Codes	Failure to Align (2522); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, while checking alignment for drilling the distal screw hole using a targeting device which was made in (b)(6) the drill interfered with the nail (around static hole).The nail was used and no return.Procedure was completed by free hands.Delay 60 minutes reported.Backup device not available.No injury or impact to patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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, the clinical information provided is insufficient to determine the root cause of device failure to align.Based on the information provided, the surgeon changed the procedure to a freehand technique.Per report, there was a 60-minute delay and a backup device was not available.Since there was, no injury or impact to the patient, 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 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.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.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 10S 10MM X 26CM 125D LEFT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10551763
• Report Number: 1020279-2020-04654
• Device Sequence Number: 19717351
• Product Code: JDS
• UDI-Device Identifier: 00885556343746
• UDI-Public: 00885556343746
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: 71675501
• Device Catalogue Number: 71675501
• Device Lot Number: 20EM04773
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 06/30/2021
• 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: Required Intervention