MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN 6 DEG VALG COL NTRAL S3-8; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71434404
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection of the neutral collet assembly did not confirm any obvious signs of damage or deformation that would cause the device to fail.The device was manufactured in 2005 and exhibits signs of wear and use around the neutral out collet.A functional inspection of the collet confirmed the complaint that the device does not turn as intended.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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Event or Problem Description
It was reported that the items were found broken.This was found during set up / inspection.No surgery or patient involvement.

• Brand Name: LGN 6 DEG VALG COL NTRAL S3-8
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10657418
• Report Number: 1020279-2020-05306
• Device Sequence Number: 2554778
• Product Code: OLO
• UDI-Device Identifier: 03596010550170
• UDI-Public: 03596010550170
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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: 71434404
• Device Catalogue Number: 71434404
• Device Lot Number: 05LM01748
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALIGNMENT GUIDE 71434330, LOT 05LM01748.