MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71368569

Device Problems Degraded (1153); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Information (3190)

Event Date 12/05/2018

Event Type  malfunction  

Event Description

It was reported that, during surgery, device was not working properly.No back-up was available.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection of the returned r3 offset impactor indicated that the thumb release no longer holds.A functional evaluation indicated that the linkage does not function smoothly.The plastic impactor tip is missing.Failure to use this tip may result in the distal linkage section to become damaged and the overall device not functioning as intended.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch.We recommend that all re-usable instruments be routinely inspected for wear/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 complaint will be reopened.

• Brand Name: R3 OFFSET IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8210199
• MDR Text Key: 131851381
• Report Number: 1020279-2019-00016
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010600240
• UDI-Public: 03596010600240
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• 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: 01/18/2019

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 Catalogue Number: 71368569
• Device Lot Number: 18DM06021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1