MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 13X40 130D RT; NAIL, FIXATION, BONE

Model Number 71676626

Device Problems Connection Problem (2900); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a rt hip im nailing, surgeon was unable to fit the lag drill sleeve into the 130 drop.Post procedure, it was noticed there was an issue with the drop being warped.The procedure was completed without delay using a smith & nephew back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.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 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 1.5 13X40 130D RT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11256939
• MDR Text Key: 229574862
• Report Number: 1020279-2021-00808
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556039663
• UDI-Public: 00885556039663
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71676626
• Device Catalogue Number: 71676626
• Device Lot Number: 19BM14853A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention