MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR TIP; PRSTHSS, KNEE, FMRTBL, SM-CNSTRIND, CMNTD, MTL/PLYMR

Model Number 71363077

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  malfunction  

Event Description

It was reported that during surgery the device tip cracked into several pieces while inserting the cup.No delay nor injury was reported.A backup device was available.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A small section fractured off the device, rendering it inoperable.All pieces were returned.The device has numerous nicks and gouges in surface, particularly around the fracture site.The device 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.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.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 for future complaints and investigate as necessary.

• Brand Name: R3 OFFSET IMPACTOR TIP
• Type of Device: PRSTHSS, KNEE, FMRTBL, SM-CNSTRIND, CMNTD, MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9792355
• MDR Text Key: 182147730
• Report Number: 1020279-2020-00785
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 71363077
• Device Catalogue Number: 71363077
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Date Manufacturer Received: 05/06/2020
• Patient Sequence Number: 1