MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 LINER IMPACTOR HEAD 32MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71368132

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Event Description

It was reported that during surgery both instruments broke while impacting the r3 liner.The 32 mm trial broke inside the patient.A piece did fall inside, but all pieces were recovered.There was a backup device available.There were no delays in the procedure and no patient injuries reported.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured into two pieces and both pieces were returned.The device was manufactured in 2008 and exhibits signs of extensive wear / usage.A review of complaint history did not reveal additional complaints for the listed batch.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 product failed to meet any product specifications at the time of manufacture.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.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured into two pieces and both pieces were returned.The device was manufactured in 2008 and exhibits signs of extensive wear / usage.A review of complaint history did not reveal additional complaints for the listed batch.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 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 LINER IMPACTOR HEAD 32MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9380471
• MDR Text Key: 177165821
• Report Number: 1020279-2019-04172
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2020

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
• Device Operator: No Information
• Device Catalogue Number: 71368132
• Device Lot Number: 08MDS0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/10/2019; 01/27/2020
• Supplement Dates FDA Received: 12/18/2019; 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1