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

Catalog Number 9560524

Device Problems Device Inoperable (1663); Material Deformation (2976)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was pre-operatively diagnosed with lumbar disc herniation and underwent micro endoscopic discectomy.During the surgery, the flexible arm could not be fixed firmly due to wear of thread.The product came in contact with the patient.No patient complications were reported as the result of the event.There was a delay of less than 60 minutes.

Manufacturer Narrative

Product analysis: visual and functional evaluation revealed that the tension wheel and the mating threads are all that were returned.The interfacing threads have been damaged from what appears to be torsional overload.The tightening of the flex arm can place high pressure on the threads that can cause them to be damaged.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Type of Device: 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7604452
• MDR Text Key: 111148156
• Report Number: 1030489-2018-00852
• 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: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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: MY17D001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• 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