MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SCREWDRIVER

Catalog Number	5484147
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not 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
Pre-op diagnosis: scoliosis in thoracic vertebra part levels implanted: t2-l3 it was reported that on (b)(6) 2018, during a operation to extend the inline connector, tip of the driver broke while inserting the set screw again during extension.No fragments of the driver were remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis result: visual hardness visually confirmed approximately 2.5mm of the instrument tip has been broken off, consistent with interface during usage.Microscopic examination of the fracture surface reveals a fairly flat fracture surface and circular material movement, consistent with torsional overload, consistent with torsional overload condition.The hardness of the sheared tip meets print spec.The above findings are consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7649985
• Report Number: 1030489-2018-00934
• Device Sequence Number: 19298223
• Product Code: HXX
• UDI-Device Identifier: 00613994591937
• UDI-Public: 00613994591937
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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: 5484147
• Device Lot Number: GB17E003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1