MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HOUSING RESECT COLLET S3-8; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number	71440001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, screw got jammed up and then just fell apart.Nothing got in patient.No injury to patient.Backup device available.
Additional Manufacturer Narrative
T was reported that during surgery, screw got jammed up and then just fell apart.Nothing got in patient.The associated genesis ii spc housing collet was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.The device was manufactured in 2015.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.The housing collet is a reusable device that can be exposed to numerous surgeries; damage from repeated use can occur.Several potential factors that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN HOUSING RESECT COLLET S3-8
• 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: 8493823
• Report Number: 1020279-2019-01463
• Device Sequence Number: 1783428
• Product Code: MBH
• UDI-Device Identifier: 03596010549327
• UDI-Public: 03596010549327
• 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
• Report Date (Section B): 12/20/2019

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: 71440001
• Device Lot Number: 15AAB0007
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1