MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 18CM 125D; NAIL, FIXATION, BONE

Model Number 71675383

Device Problem Difficult to Insert (1316)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2020

Event Type  malfunction  

Event Description

It was reported that during surgery upon trying to attach nail to guide, the scrub tech could not get the guide bolt to turn more than an eighth of a rotation.The guide was flush against the top of the nail and the nail was aligned correctly with the axis of the guide, nevertheless after multiple attempts we tried the second bolt in the set with the same results.At this point the dr.Wanted a new nail in fear that if we tried anymore the nail would become cross threaded causing it to bind and presenting issues when trying to remove guide further along in the surgery.A new nail was open and attached to guide with no problems and the surgery was completed as per usual.No delay nor injury reported.

Manufacturer Narrative

H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from attempted use.The medical investigation concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation, and it is unknown if the reported issue caused a delay during the procedure.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A dimensional inspection of the device threads found them to be out of specification, confirming the stated failure.This issue was investigated through our internal nonconformance process and was found to be isolated at this time.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 have reason to suspect that the product failed to meet product specifications at the time of manufacture.The potential probable cause for this event is likely a manufacturing process error.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 10S 10MM X 18CM 125D
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10205125
• MDR Text Key: 196742811
• Report Number: 1020279-2020-02807
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556105696
• UDI-Public: 00885556105696
• Combination Product (y/n): N
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71675383
• Device Catalogue Number: 71675383
• Device Lot Number: 20DM05725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1