MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 LINER IMPACTOR HEAD 32MM; PRSTHSS, HP, HM-, TRNNN-BRNG, FMORL, MTL/PLYCTL

Catalog Number 71368132

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2020

Event Type  Injury  

Event Description

It was reported that during surgery while instrument was inside the patient device cracked.The procedure was completed with a delay less than 30 minutes with a smith&nephew back up device.No harm or injury was reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this complaint from the united states reports that the r3 liner impactor cracked during surgery.¿the procedure was completed with a delay less than 30 minutes with a smith&nephew back up device.¿ no information about the patient status has been provided.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A visual inspection confirmed a part is broken off the r3 liner impactor head 32mm and has not been returned.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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: R3 LINER IMPACTOR HEAD 32MM
• Type of Device: PRSTHSS, HP, HM-, TRNNN-BRNG, FMORL, MTL/PLYCTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10480568
• MDR Text Key: 205245214
• Report Number: 1020279-2020-04365
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010599971
• UDI-Public: 3596010599971
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71368132
• Device Lot Number: 10LDS0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 11/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention