MAUDE Adverse Event Report: INTEGRA YORK, PA INC. HOUSE CURETTE 7-1/8 STRONG-ANG; N/A

Catalog Number 385401

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

On 5/25/17 integra investigation completed.Method: failure analysis, device history evaluation results; failure analysis - failure analysis cannot be performed based on the lack of information provided by the customer.The curette was not returned for further evaluation.Device history evaluation - dhr review: 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.The curette was not returned for further evaluation.

Event Description

Fda medwatch # mw5069354 reports that while utilizing a curette to remove fibrous tissue and cortical bone from the non-union site, the tip of the curette broke off in the middle of the phalanx.On (b)(6) 2017 no further information available.

• Brand Name: HOUSE CURETTE 7-1/8 STRONG-ANG
• 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: 6616019
• MDR Text Key: 76951854
• Report Number: 2523190-2017-00063
• Device Sequence Number: 1
• Product Code: FZS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 385401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2017
• 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