MAUDE Adverse Event Report: INTEGRA YORK, PA INC. INTEGRATOR MALLET; M54 - ORAL SURGERY

Catalog Number 015-99603

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 (b)(6) 2016.The investigation included: evaluation of actual device, review of device history records, review of complaints history.The returned integrator showing wears, repair markings and a broken center screw.The integrator was manually tested and the center screw is broken and does not function as designed.The complaint is confirmed; unsuccessful repair nonconforming product report / nonconforming material report history: none.Complaints metrics tracked, trended, and reviewed monthly with management.There was one intergrator mallet repaired (b)(6) 2016 returned used/processed showing wears, repair markings and a broken center screw.The complaint report has been confirmed as a repair issue; we have taken measures to address this issue.

Event Description

It was reported that the integrator mallet is not cocking after being repaired for the same failure six days earlier.Product was in contact with the patient however, no patient injury was reported.

• Brand Name: INTEGRATOR MALLET
• Type of Device: M54 - ORAL 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6010883
• MDR Text Key: 56931847
• Report Number: 2523190-2016-00165
• Device Sequence Number: 1
• Product Code: LXM
• Combination Product (y/n): N
• PMA/PMN Number: K950646
• 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: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 015-99603
• Device Lot Number: 1606R (1789)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Date Manufacturer Received: 09/14/2016
• 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