MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. MICROFRANCE, UNKNOWN PRODUCT ID; N/A

Catalog Number XXX-INSTRUMENT

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Device history review - dhr for lot no.4455147 reviewed and no anomalies that could be associated with the complaint were observed.The scissors insert was returned for evaluation: failure analysis: the evaluation verified the complaint as valid.The broken part is not a spring but the threading of the device.Root cause: the instrument was previously repaired / modified outside of the manufacturer by an external contractor.This modification could have weakened the device and led to the reported defect.

Event Description

A facility reported that the scissors insert cev607u had an internal broken spring.It is unknown if the device failure led to surgical delay; however, no patient injury or death has been alleged.

• Brand Name: MICROFRANCE, UNKNOWN PRODUCT ID
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 11174695
• MDR Text Key: 227007753
• Report Number: 2523190-2021-00004
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K080257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-INSTRUMENT
• Device Lot Number: 4455147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Date Manufacturer Received: 12/15/2020
• Date Device Manufactured: 02/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1