MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 VIPER UNIV POLY DRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 279734000N

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Dr. (b)(6) broke the tips of 4 screwdriver shafts.

• Brand Name: 5.5 VIPER UNIV POLY DRIVER
• 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): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7534755
• MDR Text Key: 109007676
• Report Number: 1526439-2018-50482
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 279734000N
• Device Catalogue Number: 279734000N
• Device Lot Number: GM4222402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown