MAUDE Adverse Event Report: INTEGRA YORK, PA INC. SC IRIS SCS 4-1/2 CVD; M5 - GENERAL SURGERY

Catalog Number 5-SC-306

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

On 06/02/2016 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - there were two sc iris scissors returned in used condition.One manufactured in jan.2015 and the other manufactured in march 2015 showing staining, residue, a purple tape marking on one of the handles and both tips broken.Inspected the sc iris scissors and noticed there is blackening at the break area (screw area) and also on the tip of the first one that is broken at the tip, indicating that this started out as a stress fracture and with continued use and cleaning it caused the metal to break down and eventually causing it to break.Not knowing how the scissors were processed/maintained, the complaint is confirmed.Complaint was against one scissors, can't tell which one.Device history evaluation - 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: there is no applicable corrective action preventive action history.Health hazard evaluation history: none.Conclusion: root cause has not been identified as a workmanship or material deficiency.

Event Description

Customer initially reports device is broken.On (b)(6) 2016 customer reports while cutting a cord during a dental crown, the tip broke off in mouth and was retrieved.No harm done.

• Brand Name: SC IRIS SCS 4-1/2 CVD
• Type of Device: M5 - GENERAL SURGERY
• 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: 5739982
• MDR Text Key: 47896430
• Report Number: 2523190-2016-00093
• Device Sequence Number: 0
• Product Code: HNF
• 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
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5-SC-306
• Device Lot Number: 100121-1501 & 100121-1503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Date Manufacturer Received: 06/14/2016
• 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
• Patient Age: 65 YR