MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRN II BCS LCK FEM IMPLANT IMPACT; PRSTHS, KNEE, PATFEMIB, SEMI-CNSTRND, CMNTD, POLY/MET/POLY

Model Number 74012812

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  malfunction  

Event Description

It was reported that, during spd cleaning, the attachment arm of the fem implant impact was noticed cracked.As this was noticed in a non-surgical environment, there was not any patient involved.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned impactor confirms the cam arm has a crack in it, rendering the device inoperable.The device shows signs of significant wear and 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 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.

• Brand Name: JRN II BCS LCK FEM IMPLANT IMPACT
• Type of Device: PRSTHS, KNEE, PATFEMIB, SEMI-CNSTRND, CMNTD, POLY/MET/POLY
• 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: 12763406
• MDR Text Key: 282581592
• Report Number: 1020279-2021-07878
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556003541
• UDI-Public: 00885556003541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012812
• Device Catalogue Number: 74012812
• Device Lot Number: 18CST0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1