MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC POWEREASE INSTRUMENTS; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number 2342301M

Device Problem Break (1069)

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

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a user facility regarding a patient for unknown spinal therapy.It was reported that the driver was broken.The patient involvement was unknown in the event and no further complications were reported.Additional information was received on 2021-jan-22: the event happened during intra-op.No allegation was reported but the device malfunctioned by stripping with normal wear and tear.There was patient involved in the event and no patient complications involved in the event.Patient outcome is fine, no injury.Therapy involved in the event was reconstructive deformity spinal surgery.The products came in contact with the patient.The case was a revision surgery.No ¿prolongation¿ of hospital stay or additional surgery.The lot number of the reported products is ct19c091.

• Brand Name: POWEREASE INSTRUMENTS
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• 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: 11283901
• MDR Text Key: 240922715
• Report Number: 1030489-2021-00143
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2342301M
• Device Catalogue Number: 2342301M
• Device Lot Number: CT19C091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2019
• 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