MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. PUNCH 3712039 CIRCULAR CUT 3.5MM 60DG UP; PFM11

Catalog Number 3712039

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that there was no hole that seems to be the rear cleaning port on the punch circular cut (3712039).It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.

Manufacturer Narrative

The customer advised that the punch circular cut (3712039) would not be returned for investigation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The issue reported by the customer could not be determined.The issue of not cleaning through the rear port may be the result of a blockage or improper cleaning.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: PUNCH 3712039 CIRCULAR CUT 3.5MM 60DG UP
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• MDR Report Key: 12089269
• MDR Text Key: 261704785
• Report Number: 2523190-2021-00134
• Device Sequence Number: 1
• Product Code: KAY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3712039
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1