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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME INSERTER CARRIER SURGICAL SCREWDRIVER, REUSABLE

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DEPUY SPINE INC VIPER PRIME INSERTER CARRIER SURGICAL SCREWDRIVER, REUSABLE Back to Search Results
Model Number 286750033
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2022
Event Type  malfunction  
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. If the information is unknown, not available or does not apply, the section/field of the form is left blank. Additional narrative: a device history review was performed, and no non-conformances were detected related to the reported condition. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a j&j sales representative. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, during a posterior lumbar interbody fusion (plif) for treating spinal canal stenosis the inserter handle was attached to the inserter carrier and a red powder-like foreign substance came out. They reattached the devices a few times, but the foreign substance came out over and over. The devices were not used in the procedure, and the procedure was completed without surgical delay. This report is for one (1) viper prime inserter carrier. This is report 2 of 2 for complaint (b)(4).
 
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Brand NameVIPER PRIME INSERTER CARRIER
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 Key14222794
MDR Text Key294270397
Report Number1526439-2022-00624
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K170937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number286750033
Device Catalogue Number286750033
Device Lot NumberMF4407603
Was Device Available for Evaluation? No
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2020
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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