MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CONE IMPACTOR HANDLE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED,

Model Number	71442011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during a tka procedure, the piece that holds the rasp and trial of the lgn cone impactor handle broke off inside the patient.All the pieces were accounted.The procedure was finished using a smith and nephew back up device.No surgical delays and no injuries to patient were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.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.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned lgn cone impactor handle confirms significant signs of usage and wear.The reported issue is confirmed as the piece that holds the rasp and trial broke off.The broken piece was not returned with the device.A review of complaint history on the listed part revealed no prior complaint 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.A review of the risk management file revealed this failure mode was previously identified.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 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 CONE IMPACTOR HANDLE
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11391023
• Report Number: 1020279-2021-01655
• Device Sequence Number: 14267036
• Product Code: MBH
• UDI-Device Identifier: 00885556537152
• UDI-Public: 00885556537152
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/11/2021; 05/21/2021
• Initial Report FDA Received Date: 02/28/2021
• Supplement Report FDA Received Date: 03/15/2021; 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention