MAUDE Adverse Event Report: INTEGRA YORK, PA INC. FOMON RASP TC 8.25 DE 5/6 COARSE/COARSE BACKWARD; M12 - PLASTIC SURGERY

Catalog Number 21-382TC

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on september 15, 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; the returned fomon rasp tc showing staining/pitting within grooves was tested with plastic round profile.Inserts grasped material as intended.There was no signs of the insert sliding off of material.Dhr review; no nonconforming product report / nonconforming material report history.No corrective action preventive action history/corrections.No health hazard evaluation history.Complaints history; complaints metrics tracked, trended, and reviewed monthly with management.Conclusion: the complaint is unconfirmed; testing within specification.

Event Description

It was reported that both grasps edges fail to grasp septum bone firmly.According to customer, is not meeting quality standards.Device was in contact with the patient however, no patient injury reported and the event lead to surgical delay, unknown for how long.

• Brand Name: FOMON RASP TC 8.25 DE 5/6 COARSE/COARSE BACKWARD
• Type of Device: M12 - PLASTIC SURGERY
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6028411
• MDR Text Key: 57797821
• Report Number: 2523190-2016-00176
• Device Sequence Number: 1
• Product Code: GAC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-382TC
• Device Lot Number: 100194-1507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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