MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CARB-BITE MAYO-HEGAR NH 8; N/A

Catalog Number 121145

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/01/2016

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

Customer initially wants product inspected, says the product has a burr or something on the edge of the product, possible nick or scrape that catches on the sutures.(b)(6) 2016, customer reports intervention was that they used another needle holder that had the same issue.A suture was torn using the needle holder, no harm to patient.

Manufacturer Narrative

2/19/16 integra investigation completed.Method : failure analysis, device history evaluation.Results : failure analysis - four needle holders returned in used condition, not showing any unusual markings.The four needle holders were actually returned within there original packaging showing no wear.Upon the evaluation of the instruments, no defects where found in the working area of the needle holder.It is noticed that one needle holder has a small finishing defect (burr) in the lock box area.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 : the complaint has been unconfirmed; testing within specifications.

• Brand Name: CARB-BITE MAYO-HEGAR NH 8
• 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: 5449200
• MDR Text Key: 38639654
• Report Number: 2523190-2016-00015
• Device Sequence Number: 1
• Product Code: DWS
• 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,Followup
• Report Date: 02/03/2016

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: 121145
• Device Lot Number: 5990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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