MAUDE Adverse Event Report: CLARIANCE SAS ERISMA-LP NAVIGATED INSTRUMENTS; ERISMA-LP NAVIGATED DRIVER

Model Number 48710003

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

The surgeon had to use a different system delaying the surgery by 30 minutes.

Event Description

Both screwdrivers available in erisma-lp navigated instruments would not disengage from the screw while being implanted.It was disassembled and reassembled by "sterile processing department" incorrectly, causing the locking mechanism to function abnormally.The surgeon had to use a different system delaying the surgery by 30 minutes.

• Brand Name: ERISMA-LP NAVIGATED INSTRUMENTS
• Type of Device: ERISMA-LP NAVIGATED DRIVER
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer (Section G): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer Contact: fadwa bahr ; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 12207186
• MDR Text Key: 264951217
• Report Number: 3009962553-2021-00003
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 03700780638222
• UDI-Public: 03700780638222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48710003
• Device Catalogue Number: 48710003
• Device Lot Number: M3K4X/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1