MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC OTHER EXTRA-DISCAL; SCREWDRIVER

Model Number	815-518
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a spinal product using drivers for a posterior fusion and corpectomy.It was reported that the driver tips sheared off during hardware removal.Broken fragments were recovered and alternative instruments used.The instruments broke and there were no fragments of the instruments remaining in the patient's body.The driver broke during the extension/revision surgery.We used alternative drivers to remove the implants.There were no patient symptoms or complications as a result of the event.The patient came in contact with the instruments.The pre-op diagnosis was extension/ revision of fusion.The levels implanted were t4-t9.There was no treatment or additional surgery performed as a result of this event.Medtronic products were used in the initial surgery and had no malfunction that resulted in the revision surgery.Patient suffered subsequent injury after initial surgery and required additional stabilization.The products will be replaced by medtronic products in the future.The patient's medical history includes obesity.No further complications were reported/ anticipated.

• Brand Name: OTHER EXTRA-DISCAL
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10827400
• Report Number: 1030489-2020-01635
• Device Sequence Number: 14363707
• Product Code: HXX
• UDI-Device Identifier: 00673978045092
• UDI-Public: 00673978045092
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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
• Operator of Device: Health Professional
• Device Model Number: 815-518
• Device Catalogue Number: 815-518
• Device Lot Number: KH15K045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 159