MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 6MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SMI-CONSTRAINED, CMNTD, METAL/POLYMR

Model Number	71434306
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an s and n knee revision, the coupler wasn't engaging one of the washers within the coupler was broken.No injuries or delays reported.A backup device was available.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation, the reported event could not be confirmed.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 complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Based on this investigation, the need for corrective action is not indicated.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Without the actual product involved, our investigation cannot proceed.

• Brand Name: LGN OFFSET COUPLER TRIAL 6MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SMI-CONSTRAINED, CMNTD, METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9714437
• Report Number: 1020279-2020-00557
• Device Sequence Number: 2512970
• Product Code: HRY
• UDI-Device Identifier: 03596010547989
• UDI-Public: 03596010547989
• Combination Product (Y/N): N
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2020

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: 71434306
• Device Catalogue Number: 71434306
• Device Lot Number: 06CM17133
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/21/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1