MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC METRX SYSTEM; ARTHROSCOPE

Model Number 9560100

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

Product id: 9560100; lot number: 1201230r; (b)(6) team confirmed orientation ring is loose.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a service and repair regarding a patient for an unknown spinal therapy.It was reported that the orientation ring is loose.There was no patient involved in the event, and no further complications were reported.Additional information was received on 2020-sep-25: the event occurred during procedure.There was patient involved in the event and product came in contact with the patient, but there is no impact to patient.The procedure involved in the event was micro endoscopic discectomy (med), and the information regarding event date was unknown.Additional information was received on 2020-sep-28: there is no special report from person in-charge regarding revision surgery/ in- patient, or prolongation of existing hospitalization/ additional surgery/ delay in overall procedure time.

• Brand Name: METRX SYSTEM
• Type of Device: ARTHROSCOPE
• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10716945
• MDR Text Key: 212480242
• Report Number: 1030489-2020-01463
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9560100
• Device Catalogue Number: 9560100
• Device Lot Number: 1201230R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1