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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER PRIME NAVIGATION INSERTER DRIVE TUBE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDOS INTERNATIONAL SàRL CH VIPER PRIME NAVIGATION INSERTER DRIVE TUBE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 286750042
Device Problem Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for a surgery. During the surgery, the viper prime navigated driver shaft slightly loosened itself from the driver tube. The stylus not fully going out of the screw as expected (5 mm). The red handle was not turning smoothly (gripped). The stylus was not fully extending outside the screw as expected. Not a problem of loose shaft onto tube. The surgery was completed successfully with 25 minutes delay. There was no patient consequence. Concomitant device reported: viper prime inserter carrier (part# unknown, lot# unknown, quantity 1), unknown screws; (part# unknown, lot# unknown, quantity unknown ); unknown hammer/mallet (part# unknown, lot# unknown, quantity unknown ). This report is for (1) viper prime navigation inserter drive tube. This is report 3 of 4 for (b)(4).
 
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Brand NameVIPER PRIME NAVIGATION INSERTER DRIVE TUBE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
BRIDGEWATER DISTRIBUTION
50 scotland boulevard
bridgewater MA 02324
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key10843250
MDR Text Key216366903
Report Number1526439-2020-02191
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K170937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number286750042
Device Catalogue Number286750042
Device Lot NumberMF4376208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/16/2020 Patient Sequence Number: 1
Treatment
PRIME STYLET DEPTH ADJUSTOR; UNKNOWN HAMMER/MALLET; UNKNOWN SCREWS; VIPER PRIME INSERTER CARRIER; VIPER PRIME INSERTER CARRIER; VIPER PRIME INSERTER HANDLE
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