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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 VIPER UNIV POLY DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENTS
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DEPUY SPINE INC 5.5 VIPER UNIV POLY DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENTS Back to Search Results
Model Number 279734000N
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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.
 
Event Description
It was reported that on (b)(6) 2021, the patient underwent for a surgery.During posterior spinal fusion surgery while placing the l4 left side pedicle screw the tip of the screwdriver broke.The tip of the screwdriver was stuck in the head of the screw and was not able to be removed.Fragments were generated.There was a surgical delay of ten (10) minutes.There were no patient consequences.The procedure was successfully completed.Concomitant device reported.5.5 viper univ poly driver (part# 2797-34-000n, lot# gm5358804, qty1) this complaint involves two (2) devices.This report is for (1) 5.5 viper univ poly driver this report is 1 of 2 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.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 review of the receiving inspection (ri) for 5.5 viper univ poly driver was conducted identifying that lot number gm5358804 was released in a single batch.Batch1: lot qty of (b)(4) were released on (b)(6) 2019 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
 
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Brand Name
5.5 VIPER UNIV POLY DRIVER
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENTS
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key12267216
MDR Text Key264742738
Report Number1526439-2021-01598
Device Sequence Number1
Product Code OLO
UDI-Device Identifier10705034388410
UDI-Public10705034388410
Combination Product (y/n)N
PMA/PMN Number
K140927
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number279734000N
Device Catalogue Number279734000N
Device Lot NumberGM5358804
Was Device Available for Evaluation? No
Date Manufacturer Received08/27/2021
Patient Sequence Number1
Treatment
POLYAXIAL SCREW DRIVER SHAFT; UNKNOWN SCREWS; POLYAXIAL SCREW DRIVER SHAFT; UNKNOWN SCREWS
Patient Age57 YR
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