MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CARB-EDGE FLUSH WIRE CUTTER 7; N/A

Catalog Number 275525

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

On 10/17/2016 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history analysis: results: failure analysis - one carb-edge d/a wire cut returned in used condition, showing minimal wear, staining spots, chipped and corroded inserts.The inserts are damaged typically from hitting a hard surface or cutting something other than the intended.The complaint is confirmed as damaged/worn.Device history analysis - nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history.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: there were no applicable corrective action preventive action history/corrections.Health hazard evaluation history: none.Conclusion: the root cause of the damage has not been identified as a workmanship or material deficiency.

Event Description

Customer initially reports tungsten carbide jaws are chipping when performing the intended use.On ( (b)(6) 2016 customer reports there is no further specific information.

• Brand Name: CARB-EDGE FLUSH WIRE CUTTER 7
• 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: 6035287
• MDR Text Key: 57811105
• Report Number: 2523190-2016-00170
• Device Sequence Number: 1
• Product Code: HXZ
• 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: Health Professional
• Type of Report: Initial
• Report Date: 09/26/2016

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: 275525
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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