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

Catalog Number	5484336
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2019
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
It was reported that patient with pre-operative diagnosis of lumbar canal stenosis and spondylolisthesis underwent posterior lumbar interbody fusion at l4/5 on (b)(6) 2019.Intra-op, the tip of the reduction set screw breaker broke off and got stuck in the set screw.The tip of the product broke during final tightening and remained in the set screw.The set screw was removed, and new set screw was opened and used with another driver.It was confirmed that there was no foreign substance after checking visually and with the images and x-ray.There was a delay of less than 60 mins in procedure time as a result of alleged event.There were no patient complications as a result of alleged event.Reportedly, there was squeaking sound when final tightening was performed.
Additional Manufacturer Narrative
Product analysis: visual and optical examination confirmed approximately 3mm of instrument tip has been broken off, consistent with interface during usage.Fracture surface analysis revealed a fairly flat fracture surface and circular material movement.This type of damage is 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: 9283885
• Report Number: 1030489-2019-01278
• Device Sequence Number: 13484627
• Product Code: HXX
• UDI-Device Identifier: 00613994946591
• UDI-Public: 00613994946591
• 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): 03/30/2020

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 Catalogue Number: 5484336
• Device Lot Number: FA15C015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR