MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PLATE CUTTING FORCEPS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 71170047

Device Problem Dull, Blunt (2407)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

It was reported that the plate cutting forceps are dull.There was no case involved.

Manufacturer Narrative

The device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the plate cutting forceps show nicks, which would cause the device not to function as intended.The device shows significant signs of wear/usage.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Additional information: d4.

• Brand Name: PLATE CUTTING FORCEPS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10591708
• MDR Text Key: 208711797
• Report Number: 1020279-2020-04911
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010180803
• UDI-Public: 03596010180803
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

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: 71170047
• Device Catalogue Number: 71170047
• Device Lot Number: 14ETDK026
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1