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

Catalog Number	2342281M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the patient underwent scoliosis surgery at t11-l3.Intra-op, during screw insertion, the weld of the screwdriver came apart.New driver was opened to complete the case.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Product analysis: the tip of the center shaft has broken at the weld where it meets the main portion of the shaft.There are no obvious signs of a defect in the weld.There are witness marks on the tip indicating that torsional pressure was applied.This is consistent with overload.Additional information: if information is provided in the future, a supplemental report will be issued.

• Brand Name: POWEREASE INSTRUMENTS
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7788341
• Report Number: 1030489-2018-01146
• Device Sequence Number: 13832405
• Product Code: HBE
• UDI-Device Identifier: 00613994905604
• UDI-Public: 00613994905604
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K111520
• 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,Followup
• Report Date (Section B): 10/26/2018

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 Catalogue Number: 2342281M
• Device Lot Number: CT11J049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1