MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN 6 DEG VAL COL 2MM OFF S3-8; PROSTH, KNEE, PATELLO/FEM, SEMI-CONS, UNCEM, POROUS, COATED, POL/METAL/POLY

Model Number	71434405
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during revision surgery the valgus collet 2 mm was seized and would not rotate on the reamer shaft.The procedure was finished using a smith and nephew backup device.No delay or patient harm was reported.
Additional Manufacturer Narrative
Case-(b)(4).D4: lot number updated.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device has minor scratches on the device.The device shows signs of extensive use.A dimensional inspection of the returned device states the "damage around the locking mechanism was noted.The internal diameter of the inner collet was slightly collapsed in its free state which caused difficulty in passing the appropriate pin through the id.Once the.372/.375 pins were engaged in the id, the device functioned as intended with the functional gage (f-1005").A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.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: LGN 6 DEG VAL COL 2MM OFF S3-8
• Common Device Name: PROSTH, KNEE, PATELLO/FEM, SEMI-CONS, UNCEM, POROUS, COATED, POL/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10782053
• Report Number: 1020279-2020-06099
• Device Sequence Number: 17087138
• Product Code: MBH
• UDI-Device Identifier: 03596010549136
• UDI-Public: 03596010549136
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2021

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: 71434405
• Device Catalogue Number: 71434405
• Device Lot Number: 06GM06034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 08/11/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 08/09/2021; 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1