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

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).

• Brand Name: VIPER PRIME NAVIGATION INSERTER DRIVE TUBE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL 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 Key: 10843250
• MDR Text Key: 216366903
• Report Number: 1526439-2020-02191
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170937
• Number of Events Reported: 1
• 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 Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 286750042
• Device Catalogue Number: 286750042
• Device Lot Number: MF4376208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2019
• 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