MAUDE Adverse Event Report: INTEGRA YORK, PA INC. FORCEPS MCO13C ALLIG 3X0.6MM HARTMAN; PFM11

Catalog Number MCO13C

Device Problem Break (1069)

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 the forceps mco13c was broken during an unspecified procedure even though it was not touched on a hard place after the first use.There was no patient injury and no surgery delay.However, it is unknown how the procedure was completed.

Manufacturer Narrative

Mco13c forceps was not returned for evaluation; 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.However, this issue may be due to a bad handling of the device during the first cleaning, a material defect or a manufacturing defect.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.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.The forceps were returned for evaluation: dhr - no anomalies that could be associated with the complaint were observed failure analysis - the pin between the jaws and the slide part is missing.The slide part is bent.Root cause - this issue is probably due to an improper handling of the device during the first cleaning or the storage.

Event Description

N/a.

• Brand Name: FORCEPS MCO13C ALLIG 3X0.6MM HARTMAN
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 11854403
• MDR Text Key: 251715559
• Report Number: 2523190-2021-00105
• Device Sequence Number: 1
• Product Code: KAE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCO13C
• Device Lot Number: 4453443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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