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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC UNIVERSAL NAVIGATION VIPER SYSTEM TAP, DUAL LEAD CANNULATED 6MM ORTHOPAEDIC STEREOTAXIC INSTRUMENT

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DEPUY SPINE INC UNIVERSAL NAVIGATION VIPER SYSTEM TAP, DUAL LEAD CANNULATED 6MM ORTHOPAEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 286715600N
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during cleaning, bone matter could not be removed from the instrument. This report involves one (1) universal navigation viper system tap, dual lead cannulated 6mm. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a synthes employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.
 
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a synthes employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during cleaning, bone matter could not be removed from the instrument. This report involves one (1) universal navigation viper system tap, dual lead cannulated 6mm. This is report 1 of 1 for (b)(4).
 
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Brand NameUNIVERSAL NAVIGATION VIPER SYSTEM TAP, DUAL LEAD CANNULATED 6MM
Type of DeviceORTHOPAEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key13203542
MDR Text Key286346595
Report Number1526439-2022-00060
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K140927
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number286715600N
Device Catalogue Number286715600N
Device Lot NumberNG86143
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2019
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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