MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN STYLUS 1MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71434333
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device, used in treatment, was returned and evaluated. a visual inspection of the returned device confirmed the stated failure mode.The device is fractured and the fractured piece was returned, rendering the device inoperable.The device shows signs of extensive use. a review of complaint history did not reveal additional complaints for the listed batch for the same failure mode. a review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.  at this time, we do not have 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 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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during a tka surgery, a screw fell out of one lgn stylus 1mm.Incident occurred with instruments outside of the patient.Surgery was resumed, without any delay, using a smith and nephew back-up device.No health consequences were reported.The investigation found that the device was fractured.

• Brand Name: LGN STYLUS 1MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12375272
• Report Number: 1020279-2021-06573
• Device Sequence Number: 19826851
• Product Code: HRY
• UDI-Device Identifier: 03596010549839
• UDI-Public: 03596010549839
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/26/2021

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: 71434333
• Device Catalogue Number: 71434333
• Device Lot Number: 19CK00111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1