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

Model Number 71368569

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 07/30/2020

Event Type  Injury  

Event Description

It was reported that during surgery the r3 offset impactor would not release from the 56 r3 cup after impaction.Surgeon had to hit the impactor hard to seat the cup.Cup was impacted already and with the use of vice grip, surgeon twisted the orange handle until it removed from the cup.No noticeable broken pieces.Procedure concluded with same device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned r3 offset impactor confirms the locking mechanism is damaged on the device causing the stated failure.The device shows signs of significant wear/use.The device was manufactured in 2014.A medical investigation was conducted and this case reports that the r3 offset impactor would not release after impaction.Per complaint description, after the cup was seated, a vice grip was used to remove the impactor handle from the cup.The procedure was completed with the same device with no noticeable broken pieces.Since no patient harm is being alleged, no further assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and 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.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 OFFSET IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10439351
• MDR Text Key: 203977299
• Report Number: 1020279-2020-04147
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71368569
• Device Catalogue Number: 71368569
• Device Lot Number: 14JM16702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 111