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

Catalog Number	2342305M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.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.
Event or Problem Description
It was reported that patient with degenerative disc disease underwent unspecified spinal procedure at levels l2-s1.Intra-op, as the surgeon was advancing the screw, the tip of the driver broke off into the head of the screw.No fragments remained inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visually confirmed approximately ~3 mm of instrument tip has been broken off, consistent with interface during usage.Inspection of the shaft diameter and material hardness confirmed conformance to print specification.Fracture surface analysis reveals a fairly flat fracture surface and circular material flow, consistent with torsional overload.The above findings are consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6867791
• Report Number: 1030489-2017-02045
• Device Sequence Number: 851419
• Product Code: HBE
• UDI-Device Identifier: 00613994905697
• UDI-Public: 00613994905697
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 01/18/2018

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: 2342305M
• Device Lot Number: CT11H036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 12/19/2017; 12/19/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 01/16/2018; 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 102