MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC METRX II; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	9560523
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a service and repair regarding a patient for an unknown spinal therapy.It was reported that the ball joint cannot be secured.There was patient involved in the event and no further complications were reported.Additional information was received via manufacturer representative that reported event happened on (b)(6) 2021 during procedure.The reported product came in contact with the patient.The procedure involved in the event was micro endoscopic discectomy (med) and pre-op diagnosis was spinal canal stenosis.
Additional Manufacturer Narrative
(b)(6) service and repair report confirmed that the joint screw had come off and the fixed parts had fallen out.The screw disconnection in the joint region is not subject to repair.If information is provided in the future, a supplemental report will be issued.

• Brand Name: METRX II
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13598687
• Report Number: 1030489-2022-00194
• Device Sequence Number: 16608659
• Product Code: LXH
• UDI-Device Identifier: 00721902322532
• UDI-Public: 00721902322532
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: Health Professional
• Device Model Number: 9560523
• Device Catalogue Number: 9560523
• Device Lot Number: MY17D001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown