MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TC REV/RT/RT MOD. EXTRACTION FORCEPS

Catalog Number 75100382

Device Problem Failure to Align (2522)

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

Event Date 05/27/2020

Event Type  Injury  

Event Description

It was reported that while using the extractor on a revision knee surgery, the peg that aligns the forceps and allows them to retract was knocked loose.A change of the surgical technique was necessary in order to complete the procedure.It is not known if the revision surgery was performed due to s+n devices.

Manufacturer Narrative

An extraction forceps rt-plus modular was reported that during use on a revision knee, the peg that aligns the forceps was knocked loose.The complaint device, used for treatment, was returned and to the legal manufacturer mps precimed for investigation.Mps precimed confirms that one of the screws c10786 is missing.Although the screw has been reported broken, it has not been shipped.Therefore, mps precimed cannot confirm whether the screw is broken or lost.The production documentation was reviewed.No deviations were found which could have led to the reported issue.The material certificate was checked.All components have been manufactured and conformed to the specifications.The severity and occurrence of the failure mode are covered through the risk management file.A mechanical testing of the component has been performed through mt-o110-19.The report indicates a torque resistance around 8.7 n.M.Corrective and preventive action plan of the complaint (b)(4) is still in process and currently evaluates if a raw material change could increase the mechanical resistance of the screw.For the medical investigation, additional documentation has been requested but has not become available.It was reported that a change of surgical technique was required and the procedure was completed with a replacement device, with no injury to the patient reported.It was stated that it is unknown if the revision surgery was performed due to s+n devices.No further medical assessment is warranted based on the information provided.Considering that the screw broke as described (no returned broken screw), the root cause comes from a misuse where an unnecessary strong torque has been applied on the screw to lock it.The average torque resistance at 8.7 nm demonstrates that the screw resist to couple that seems to be reasonable regarding the use of the device.This is normally not necessary to tight strongly the screw to obtain the intended use of the device.The screw seems to be screwed more than necessary, up to the breakage.Corrective action plan tracked through complaint (b)(4).Mps precimed will continue to monitor for trends.Smith+nephew will continue to monitor for similar issues and the third party devices will be forwarded to the legal manufacturer for investigation.The complaint device was sent to the legal manufacturer.

Manufacturer Narrative

This event should be re-evaluated for mdr reporting since smith & nephew is not the legal manufacturer of the device.The reassessment determined that the issue does not meet the threshold for us to reporting.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: TC REV/RT/RT MOD. EXTRACTION FORCEPS
• Type of Device: FORCEPS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10187745
• MDR Text Key: 196205510
• Report Number: 9613369-2020-00130
• Device Sequence Number: 1
• Product Code: HTD
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75100382
• Device Lot Number: T14588
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 09/28/2020; 09/28/2020
• Supplement Dates FDA Received: 09/28/2020; 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention