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

Model Number	9560523
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a manufacturer representative regarding a flex arm and bed rail attachment used for spinal therapy.It was reported that the screw could not be tightened and could not be fixated.Additional information received from manufacturer representative that procedure involved was med.Product came in contact with patient.There were no further complications reported as a result of this event.
Additional Manufacturer Narrative
Product analysis, product id:9560523, lot#:my15m002, service and repair report confirmed that the joint screw had come off and the fixation parts had fallen out, and that the bed rail clamp was defective.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: 14489798
• Report Number: 1030489-2022-00492
• Device Sequence Number: 4808585
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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: MY15M002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2015
• 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