MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR TIP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71363077

Device Problem Crack (1135)

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

Event Date 08/21/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that before a procedure, a r3 offset impactor tip is cracked.No patient involved.

Manufacturer Narrative

H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The device is broken, rendering the device inoperative.The device may have been cracked initially, but missing a piece when returned.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 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 future complaints and investigate as necessary.

• Brand Name: R3 OFFSET IMPACTOR TIP
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12472106
• MDR Text Key: 271459264
• Report Number: 1020279-2021-06864
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010599391
• UDI-Public: 03596010599391
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

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
• Device Operator: Health Professional
• Device Model Number: 71363077
• Device Catalogue Number: 71363077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1