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

Catalog Number	71675523
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, calibration of the device was performed outside the patient to confirm the alignment of a drill and distal screw holes on the nail; however, it was found that the tip of the drill interfered with the nail.The procedure was completed almost free hand (the device was used, however without relying on the device).Surgery was delayed for 15 minutes.The patient was not harmed.After the surgery, the sales rep confirmed that the device worked correctly with other nail, so the complained device is the nail that remains in the patient.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: INTERTAN 10S 10MM X 26CM 125D RIGHT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10135527
• Report Number: 1020279-2020-02264
• Device Sequence Number: 11490848
• Product Code: JDS
• UDI-Device Identifier: 00885556344842
• UDI-Public: 885556344842
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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 Catalogue Number: 71675523
• Device Lot Number: 19JM15791
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2020
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 06/16/2021
• 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