MAUDE Adverse Event Report: INTEGRA YORK, PA INC. FAVALORO-MORSE STERNAL RETR; CARDIOVASCULAR RETRACTORS

Catalog Number 300253

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

The 300253 favaloro-morse sternal retractor handle has two posts that go into the gear arm.When the retractor is open these posts do not lock into the gear arm.(b)(\6) 2015 customer reports this is a general comment.Because of the orientation of the handle, the device could inadvertently lose its grip and might start to close or release the tension held by the retractor.This design change has been seen in other of same type retractor by other manufacturer.No further or specific event information available.

Manufacturer Narrative

(b)(4), integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - complaint is unconfirmed; this is due to the product not being returned for review.Device history evaluation - dhr complete with all available history.Nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.

• Brand Name: FAVALORO-MORSE STERNAL RETR
• Type of Device: CARDIOVASCULAR RETRACTORS
• 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: 5320824
• MDR Text Key: 34199729
• Report Number: 2523190-2015-00148
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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