MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC MICRO-ENDO(TM) SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 955-525

Device Problem Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: product analysis- deformation of the handle screw's screw thread was confirmed during inspection.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a flex arm assembly used in an med for a lumbar hernia at l4/5.It was reported that there was poor tightening of flex arm assembly.There was a patient involved in the event.There were no patient symptoms or complications as a result of this event.The product was used on patient and the patient was on the operating table when the product malfunctioned.There was a 5 minute delay for flexible arm replacement.No further complications were reported/ anticipated.

• Brand Name: MICRO-ENDO(TM) SYSTEM
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14729275
• MDR Text Key: 294882416
• Report Number: 1030489-2022-00550
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2022

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
• Device Operator: Health Professional
• Device Model Number: 955-525
• Device Catalogue Number: 955-525
• Device Lot Number: 84004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/17/2022
• 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: Reuse
• Patient Sequence Number: 1