MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CONE IMPACTOR HANDLE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71442011
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the screw on the back on the gold section of a legion cone impactor handle popped out.The procedure was resumed, after a non-significant delay, with the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: additional information received by the manufacturer on 21-jun-2023 identified that this event should be re-evaluated for mdr reporting.The new information received confirmed that the screw popped out on the back table, while loading up a broach.The reassessment determined that the issue does not meet the threshold for reporting and therefore, it is a non-reportable event.Device damage occurred during handling or preparation activities performed external to the patient did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §803.If further details are provided, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.B5- describe event or problem.
Event or Problem Description
It was reported that, the screw on the back of the gold section of a legion cone impactor handle popped out as it was on the back table, while loading up a broach.The procedure was resumed, after a non-significant delay, with the same device.Patient was not harmed as consequence of this problem.

• Brand Name: LGN CONE IMPACTOR HANDLE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17117610
• Report Number: 1020279-2023-01290
• Device Sequence Number: 6574616
• Product Code: JWH
• UDI-Device Identifier: 00885556537152
• UDI-Public: 00885556537152
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 71442011
• Device Catalogue Number: 71442011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown