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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC. 5.5 NAV DRIVER - SHAFT T20 SURGICAL SCREWDRIVER, REUSABLE

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DEPUY SPINE INC. 5.5 NAV DRIVER - SHAFT T20 SURGICAL SCREWDRIVER, REUSABLE Back to Search Results
Model Number 3010-19-003
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/01/2022
Event Type  Injury  
Manufacturer Narrative
Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation. Lot #, mfr site, device manufacture date: the lot number was unknown. Therefore, the expiration date and device manufacture date were unknown. Device evaluated by mfr and manufacture date: without a lot number the device history records review could not be completed. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported by the customer that during an unknown surgery on (b)(6) 2022, it was observed that the navlock expedium driver tip sheered off in the screw head upon implantation and was unable to be retrieved. It was unknown how the procedure was completed successfully. The patient was reported to be unharmed. No additional information was provided. This report is for one (1) 5. 5 nav driver - shaft t20 device. This complaint involves one (1) device.
 
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Brand Name5.5 NAV DRIVER - SHAFT T20
Type of DeviceSURGICAL SCREWDRIVER, REUSABLE
Manufacturer (Section D)
DEPUY SPINE INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
kate karberg
325 paramount drive
raynham, MA 02767
3035526892
MDR Report Key14246253
MDR Text Key293620876
Report Number1526439-2022-00637
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3010-19-003
Device Catalogue Number301019003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/28/2022 Patient Sequence Number: 1
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