MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNI CONV TRL +4MM; MANIPULATOR, PLUNGER-LIKE JOINT

Model Number	71367903
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during total hip replacement the unipolar trial heads do not stay on the stem or broach trials.It was tried all 5 devices and the pop off non stop.A delay was reported of 10 minutes to 15 minutes.The procedure was finished using a change in the surgical technique.A different device has to be used to finished the procedure.The procedure was finished using 28 mm bipolar head.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual assessment confirmed the tandem uni conv trl +4mm is damaged at the connection site, which would cause the device not to function as intended.The device shows significant signs of wear/usage.The clinical/medical team concluded, this complaint from the united states reports that the unipolar trial heads would not stay on the stem or broach trials.Reportedly, ¿the patient is fine, the procedure was finished using a change in the surgical technique¿.A different device had to be used to finished the procedure.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.We consider this investigation closed.

• Brand Name: TANDEM UNI CONV TRL +4MM
• Common Device Name: MANIPULATOR, PLUNGER-LIKE JOINT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10293052
• Report Number: 1020279-2020-03318
• Device Sequence Number: 3484376
• Product Code: LXM
• UDI-Device Identifier: 03596010481740
• UDI-Public: 03596010481740
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71367903
• Device Catalogue Number: 71367904
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 07/18/2020
• Supplement Report FDA Received Date: 05/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention