MAUDE Adverse Event Report: INTEGRA YORK, PA INC. FERRIS-SMITH RONG 7 6X12MM STR; N/A

Catalog Number 280505

Device Problems Break (1069); Fracture (1260); Mechanical Problem (1384)

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

Event Date 11/02/2015

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

Customer initially reports ferris smith rogeur broke the first time the customer used it.On (b)(6) 2015 customer reports doctor was performing a total knee replacement removing tissue when the slide broke.No parts broke off, no harm done.

Manufacturer Narrative

2/22/16 integra investigation completed.Method : failure analysis, device evaluation history results : failure analysis - a ferris smith rongeur was returned used, showing no unusual markings and a missing pin.The rivet at the jaw has shorn off.Based on our investigation, we have no indication whatsoever that either the design, material or manufacturing process, or any circumstances within our sphere of influence have given cause for any corrective or preventative action to be initiated by us.Complaint is confirmed; device evaluation history - dhr was based on all history.Nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: no variance authorization/deviation history reported at this time.Engineering change order/manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion the complaint report is confirmed; root cause undetermined.

• Brand Name: FERRIS-SMITH RONG 7 6X12MM STR
• 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: 5234073
• MDR Text Key: 31714973
• Report Number: 2523190-2015-00127
• Device Sequence Number: 1
• Product Code: HTX
• 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: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280505
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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