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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC VIPER 2 SYSTEM TAP, CANNULATED AND SELF-DRILLING; TAP, BONE

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DEPUY SPINE INC VIPER 2 SYSTEM TAP, CANNULATED AND SELF-DRILLING; TAP, BONE Back to Search Results
Catalog Number 286715600
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2023
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 d1: viper 2 system tap, cannulated and self-drilling 6mm 30-60mm plus or minus 0.24 percent.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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 switzerland as follows: it was reported that during surgery on (b)(6) 2023, the surgeon broke off the thread cutter in the patient¿s body and had to recover it.It was reported that the surgery was completed successfully but with a delay of four hours.No further information is available.This report involves one viper 2 system tap, cannulated and self-drilling 6mm 30-60mm plus or minus 0.24 percent.This is report 1 of 1 for (b)(4).
 
Event Description
Patient status/ outcome: good outcome, left hospital this week.
 
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.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: d9.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found the tip of the viper2 6mm self drilling tap broken, the overall appearance of the device shows signs of normal use and service a dimensional inspection was not performed due to post manufacturing damage.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the device would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure , and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h6: a review of the receiving inspection (ri) for viper2 6mm self drilling tap was conducted identifying that lot number ng35300 released in one batch.Batch1: lot qty of (b)(4) units were released dec 8, 2012 with no discrepancies.Supplier: (b)(4).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.
 
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Brand Name
VIPER 2 SYSTEM TAP, CANNULATED AND SELF-DRILLING
Type of Device
TAP, BONE
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 Key18490857
MDR Text Key332616887
Report Number1526439-2024-00581
Device Sequence Number1
Product Code HWX
UDI-Device Identifier10705034214092
UDI-Public(01)10705034214092
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number286715600
Device Lot NumberNG35300
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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