MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CONE IMPACTOR HANDLE; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRIND, CMNTD, PLYMR/MTL/PLYMR

Model Number	71442011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision surgery the impactor broke while impacting.It was outside the patient and any piece fell inside the patient.A smith and nephew backup device was available to complete the procedure.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.One of the locking tabs fractured off the device, rendering it inoperable.The fractured tab was not returned.The device was manufactured in 2017 and shows signs of extensive wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality 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.

• Brand Name: LGN CONE IMPACTOR HANDLE
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRIND, CMNTD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9945870
• Report Number: 1020279-2020-01251
• Device Sequence Number: 2256352
• Product Code: JWH
• UDI-Device Identifier: 00885556537152
• UDI-Public: 00885556537152
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162775
• 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,Followup
• Report Date (Section B): 05/08/2020

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: No Information
• Device Model Number: 71442011
• Device Catalogue Number: 71442011
• Device Lot Number: 17ASC0011
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1