MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR TIP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71363077

Device Problem Break (1069)

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

Event Date 09/08/2020

Event Type  Injury  

Event Description

It was reported that during the procedure thr, the offset impactor tip cracked while being impacted.All pieces were recovered.The procedure was completed without delay and backup from smith&nephew was available to finish the surgery.No patient harm.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The visual inspection of the returned impactor tip confirms a piece of the device is broken off.The broken piece was not returned with the device.This device exhibits signs of significant use and wear.There is no lot number provided for this device.A medical investigation was conducted and this case reports the offset impactor broke during use.Per email communication, all pieces were recovered, and the procedure was completed with a backup device without a surgical delay.Therefore, since no patient harm is alleged, no further clinical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files found that the reported failure was documented appropriately.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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 TIP
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10624634
• MDR Text Key: 209743982
• Report Number: 1020279-2020-05121
• 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: 10/29/2020

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: 71363077
• Device Catalogue Number: 71363077
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/04/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention