MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CARB-BITE MICRO MH 8-1/2 SERR; CARDIOVASCULAR MICRO

Catalog Number 121231

Device Problems Break (1069); Component Missing (2306)

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

Event Date 02/18/2015

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

Medwatch report #(b)(4) states surgeon complained that castro needle driver was not holding suture correctly.After inspection castro was found to have a fragment on the inside tip missing a fragment which was approximately 3-5mm in length.Surgeon was asked if it had been like that for the entire case and he said "i don't know".Therefore unsure whether castro was damaged prior to start of procedure a chest x-ray was taken and read negative for any retained fragments by radiologist.

Manufacturer Narrative

On (b)(6) 2015 integra investigation completed.Manufacture date unknown.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 review was completed with all history available.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: 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: CARB-BITE MICRO MH 8-1/2 SERR
• Type of Device: CARDIOVASCULAR MICRO
• Manufacturer (Section D): INTEGRA YORK, PA INC. ; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4994610
• MDR Text Key: 25180634
• Report Number: 2523190-2015-00044
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2015
• 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