Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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).
 
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.H3, h4, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
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.H10 additional narrative: h3, h6: a product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned 6mm tap, dual lead cann determined that there was foreign material stuck within the device at the distal tip region and could not be removed.No other issues were identified.The dimensional inspection was not performed due to it being irrelevant to the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the 6mm tap, dual lead cann was observed to have some foreign material stuck within the tip of the device.A definitive root cause could not be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.A review of the receiving inspection (ri) for 6mm tap, dual lead cann was conducted identifying that lot number ng86143 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 25 sep2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNIVERSAL NAVIGATION VIPER SYSTEM TAP, DUAL LEAD CANNULATED 6MM
Type of Device
ORTHOPAEDIC 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
UDI-Device Identifier10705034388496
UDI-Public(01)10705034388496
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 Other
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was 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 Health Professional
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 Unknown
Patient Sequence Number1
-
-