MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK METRX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 9560524

Device Problems Break (1069); Disconnection (1171)

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

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation anticipated but not begun.

Event Description

It was reported that a flexible arm of metrx couldn't be connected.More specifically, flexible arm support assembly could not connect with bed rail.The product came in contact with the patient.No patient complications were reported.The event extended the surgery for more than 60 minutes.Surgeon's comment: the flexible arm support assembly was stiff from the time of purchase and the flexible arm broke at the second surgery.The event was the most probably due to lack of item inspection at shipping.Sales rep's comment: the connecting part with bed rail was reportedly stiff from the first surgery.Malfunction of the flexible arm assembly cannot be helped as screws inside probably got jammed by force applied from outside.Flexible arm support assembly was stiff when it was connected onto bed rail for the first time after delivery.So the surgeon determined it to be a defect from the time of delivery.Sales rep was not present at the time of delivery.The surgical time extended for 60 minutes.It reportedly resulted because of the delay at the start of the surgery.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: METRX
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5066687
• MDR Text Key: 26073569
• Report Number: 1030489-2015-02291
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/19/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 9560524
• Device Lot Number: MY15C001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Supplement Dates Manufacturer Received: 08/19/2015
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2015
• 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