MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 6 RT; PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL

Model Number 71433356

Device Problems Break (1069); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

It was reported that the femoral trials were found cracked.This was discovered after the case.No patient was affected or delays were reported.

Manufacturer Narrative

New information: d10,g4,h1,h2,h3,h6,h11.Results of investigation: the device, intended use in treatment, was returned for evaluation.A visual inspection of the returned trial confirms a crack in the metal of the device.This device was manufactured in 2011.This device exhibits signs of significant wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII SPC REAMTHRU CR TR SZ 6 RT
• Type of Device: PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10587991
• MDR Text Key: 208583402
• Report Number: 1020279-2020-04867
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00885556032725
• UDI-Public: 00885556032725
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• 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: 09/26/2020

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: 71433356
• Device Catalogue Number: 71433356
• Device Lot Number: 11AM11415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 09/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1