MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTX CEMENTED CUP X BAR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MT2201
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the x bar wasn't able to sit into the inserter.There was no delay nor injury reported.There was no backup available, it is unknown how the surgery was completed.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: MTX CEMENTED CUP X BAR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9836252
• Report Number: 1020279-2020-00900
• Device Sequence Number: 3086622
• Product Code: LXH
• UDI-Device Identifier: 03596010012302
• UDI-Public: 03596010012302
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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
• Operator of Device: No Information
• Device Model Number: MT2201
• Device Catalogue Number: MT2201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 06/02/2020
• Patient Sequence Number: 1