MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNI CONV TRL 0MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 71367900

Device Problem Flaked (1246)

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

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during set up or inspection before a tka it was noticed that the tandem uni conv trial 0mm, +45mm, +47mm, +53mm and +57mm were flaking and impacting sterilization process.The procedure was completed without delay using a smith-nephew back-up device.No patient injury or 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, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.Therefore, product analysis could not be performed at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TANDEM UNI CONV TRL 0MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11119824
• MDR Text Key: 225253104
• Report Number: 1020279-2021-00098
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010481733
• UDI-Public: 03596010481733
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71367900
• Device Catalogue Number: 71367900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1