• 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 XPDM QUICK-CON SI POLY SCWDRVR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

  • 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 XPDM QUICK-CON SI POLY SCWDRVR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 286750031
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/21/2022
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.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.
 
Event Description
Device report from synthes reports an event in canada as follows: it was reported on (b)(6) 2022, that the surgeon was doing a combined case with expedium and viper prime and several instruments were problematic during the case.One of the screwdrivers form expedium broke inside the screw head in the patient- was left inside and cannot be retrieved.The inner drivers of the flex clip reduction instruments no longer hold set screws and occasionally come off completely.The viper prime handle is damaged on the metal ring, therefore the stylet gauge cannot come easy and finally the inserter shaft from viper prime is slightly stripped at the distal end tip.There was no surgical delay.The procedure was successfully completed.The patient was not impacted, no patient info was collected, she had very hard bone which maybe why the instruments were damaged.Other instruments in the sets were used to complete the case.No further information is available this report is for one (1) xpdm quick-con si poly scwdrvr.This is report 2 of 2 for complaint (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.H10 additional narrative: d10 d10: date of concomitant therapy is (b)(6) 2022.G4 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: d4: lot number added.D10: concomitants added.H3, h4, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the distal tip viper prime inserter shaft was found stripped.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.After a visual inspection, it was determined that the reusable instrument device was stripped from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed stripped of viper prime inserter shaft would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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.Drawing/specifications reviewed? yes, reviewed.Device history lot a review of the receiving inspection (ri) for viper prime inserter shaft was conducted identifying that lot number mf4344001 was released in a single batch.¿ batch1: lot qty of 243 units were released on 13 may 2019 with no discrepancies.Device history review 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.
 
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.
 
Event Description
It was further reported that a driver was discovered to have a stripped tip.This is report 2 of 4 for (b)(4).
 
Event Description
This is report 2 of3 for pc-(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
XPDM QUICK-CON SI POLY SCWDRVR
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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 Key15414224
MDR Text Key300174284
Report Number1526439-2022-01589
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034507583
UDI-Public(01)10705034507583
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K171570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number286750031
Device Catalogue Number286750031
Device Lot NumberMF4344001
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/22/2022
Initial Date FDA Received09/13/2022
Supplement Dates Manufacturer Received10/05/2022
11/03/2022
02/02/2023
03/03/2023
Supplement Dates FDA Received10/05/2022
12/01/2022
02/15/2023
03/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
APPROXIMATOR FC SLEEVE.; UNKNOWN LOCKING/SET SCREWS.; UNKNOWN SCREWS.; VIPER PRIME INSERTER SHAFT.; VIPER PRIME PALM HANDLE.; VIPER PRIME SET SCRW INSERT.; X25 FINAL TIGHTENER.; XPDM QUICK-CON SI POLY SCWDRVR.; XPDM QUICK-CON SI POLY SCWDRVR.
-
-