MAUDE Adverse Event Report: INTEGRA YORK, PA INC. FAVALORO-MORSE STERNAL RETR; N/A

Catalog Number 300253

Device Problem Device Slipped (1584)

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

Event Type  malfunction  

Manufacturer Narrative

On 1/12/2017 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - there was a sternal retractor returned used, showing a green band marking and a loose screw.Upon further investigation, it is noticed that the screw is not seating as it should and is allowing the leaflet to move around freely and not stay secure.Not knowing how the instrument was handled/processed, the complaint report is confirmed.Device history evaluation - nonconforming product report / nonconforming material report history: none variance authorization / deviation history: none engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history/corrections: none health hazard evaluation history: none conclusion: root cause has not been identified as a workmanship or material deficiency.

Event Description

When placing the device one of the valve leaflets of the screw does not hold the position.

• Brand Name: FAVALORO-MORSE STERNAL RETR
• Type of Device: N/A
• 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: 6269156
• MDR Text Key: 65461328
• Report Number: 2523190-2017-00004
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300253
• Device Lot Number: 100132-1506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 01/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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