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 (uf) 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 (b)(6) 2021: 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.

Manufacturer Narrative

Product analysis #(b)(4): 2342301m lot # rs20a025 visual inspection confirmed approximately 3mm of the instrument tip has been broken off, consistent with interface during usage.The remaining torx tip has been twisted.Fracture surface analysis revealed a fairly flat fracture surface and circular material flow, consistent with torsional overload.This type of damage is consistent with torsional overload.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 11283884
• MDR Text Key: 230674065
• Report Number: 1030489-2021-00142
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• PMA/PMN Number: K111520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

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: RS20A025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1