MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EM TIBIAL ALIGNMENT TUBE MACRO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	74016232
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery, a pin of a em tibial alignment tube macro loosened and completely fell out.This was noticed after the proximal tibia cut was made and the instrument was laid on a back table.It is unknown if there was a significant delay in surgery, and if there was a smith and nephew back up device available.No patient injury was reported.No other complications reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment was returned for evaluation.A visual inspection was conducted and confirmed the pin and spring that connects to the device is broken off the returned em tibial alignment tube macro.The broken pieces were returned with the device.A review of complaint history did not reveal additional complaints for the listed batch.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: EM TIBIAL ALIGNMENT TUBE MACRO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11781866
• Report Number: 1020279-2021-03792
• Device Sequence Number: 16938785
• Product Code: LXH
• UDI-Device Identifier: 00885556735480
• UDI-Public: 885556735480
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 74016232
• Device Lot Number: 20HTN0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1