MAUDE Adverse Event Report: INTEGRA YORK PA, INC. INTEGRA RUGGLES - REDMOND; INSTRUMENT, MICROSURGICAL

Model Number RN6209

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 09/03/2019

Event Type  malfunction  

Event Description

During burr hole case, dura hook tip broke off, area irrigated by surgeon, tip too small to visualize.Surgeon convinced that tip isn't in the patient.Part sequestered and sent to risk.

• Brand Name: INTEGRA RUGGLES - REDMOND
• Type of Device: INSTRUMENT, MICROSURGICAL
• Manufacturer (Section D): INTEGRA YORK PA, INC.; 589 davies dr; york PA 17402
• MDR Report Key: 9179537
• MDR Text Key: 161984805
• Report Number: 9179537
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2019,09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RN6209
• Device Catalogue Number: RN6209
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2019
• Date Report to Manufacturer: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Weight: 72