MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRL 12/14 TPR FEM HD 32 -3; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	OR71353203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two pieces of inner collar broke off.Occurred inside of patient, all pieces were recovered.S&n backup device was available and was used to complete the surgery.No patient affectation, no pictures available, no closure letter needed, lot number is not on item.
Additional Manufacturer Narrative
The associated complaint device was returned to be evaluated.The visual inspection confirms two of connections tabs are broken off the device.The broken pieces were not returned.The device has multiple burrs/gouges/scratches.This device shows signs of extreme wear/usage.The device has no available lot number.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.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: TRL 12/14 TPR FEM HD 32 -3
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9220414
• Report Number: 1020279-2019-03701
• Device Sequence Number: 2106658
• Product Code: HRY
• UDI-Device Identifier: 03596010198297
• UDI-Public: 03596010198297
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/08/2019

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: OR71353203
• Device Lot Number: UNKNOWN/UNREADABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1