MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN MALE TO MALE MINI COUPLER TRL 4MM; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number	71933697
Medical Device Problem Codes	Break (1069); Fracture (1260); Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the male to male coupler set for the femoral side did not allowed to thread a stem into the coupler.The procedure went fine, just an irritating step.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Additional Manufacturer Narrative
New additional information was received for this case.
Event or Problem Description
It was reported that during a revision surgery of non-smith and nephew devices, the male to male coupler set for the femoral side was broken and did not allow to thread a stem into the coupler.The procedure was completed using the broken device, and a back-up device was not needed.The patient was not affected.

• Brand Name: LGN MALE TO MALE MINI COUPLER TRL 4MM
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8407777
• Report Number: 1020279-2019-01015
• Device Sequence Number: 2054220
• Product Code: MBH
• UDI-Device Identifier: 00885556064658
• UDI-Public: 00885556064658
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2019

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: 71933697
• Device Lot Number: 12JM00379
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/12/2019; 06/12/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 03/25/2019; 06/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1