MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 8 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71433358

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/25/2020

Event Type  malfunction  

Event Description

It was reported after the trial removed from the patient, 2 pieces of metal had broken off of the femoral trial.Both pieces were retrieved.No surgery delay.No patient harm.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this case reports that two pieces of metal broke off of the femoral trial during use.Per complaint details, both pieces were recovered, and the procedure was successfully completed without a surgical delay or patient injury.Since no patient harm is alleged, no further clinical assessment is warranted.A visual inspection confirmed the rails are cracked on the gii spc reamthru cr tr sz 8 rt.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 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.

• Brand Name: GII SPC REAMTHRU CR TR SZ 8 RT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10558111
• MDR Text Key: 207687650
• Report Number: 1020279-2020-04717
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556032312
• UDI-Public: 00885556032312
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71433358
• Device Catalogue Number: 71433358
• Device Lot Number: 11AM03482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention