MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 7 RT; PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL

Model Number	71433357
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
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 7 RT
• Common Device Name: 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: 10588204
• Report Number: 1020279-2020-04868
• Device Sequence Number: 3028646
• Product Code: MBH
• UDI-Device Identifier: 00885556031582
• UDI-Public: 00885556031582
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 71433357
• Device Catalogue Number: 71433357
• Device Lot Number: 11BM08885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 09/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1