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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC. PRIME STYLET DEPTH ADJUSTOR SURGICAL DEPTH GAUGE, REUSABLE

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DEPUY SPINE INC. PRIME STYLET DEPTH ADJUSTOR SURGICAL DEPTH GAUGE, REUSABLE Back to Search Results
Model Number 286750041
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2022
Event Type  malfunction  
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: this is report 2 of 2 for (b)(4). It was reported by the customer in (b)(6) that during a spinal fusion surgery on (b)(6) 2022, it was observed that the handle from the driver was damaged that the handle was not able to be placed on the screwdriver. It was further reported that the stylet depth adjuster end ring was damaged and completely came off while trying to remove the bent stylet from the screwdriver. Another like devices were used to complete the procedure. There were no adverse patient consequences nor surgical delay reported. No additional information was provided. This report is for one (1) prime stylet depth adjustor device. This complaint involves two (2) devices.
 
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The lot number was unknown. Therefore, the expiration date, manufacturing site name and device manufacture date were unknown. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or 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.
 
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Brand NamePRIME STYLET DEPTH ADJUSTOR
Type of DeviceSURGICAL DEPTH GAUGE, 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 Key14137327
MDR Text Key289464990
Report Number1526439-2022-00584
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K170937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number286750041
Device Catalogue Number286750041
Device Lot NumberMF4292901
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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