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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RUGGLES DIAMOND MEDIUM KERRISON RONGEUR - THIN F N/A

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INTEGRA YORK, PA INC. RUGGLES DIAMOND MEDIUM KERRISON RONGEUR - THIN F N/A Back to Search Results
Catalog Number RD4824M
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that patient in middle of surgery and item was missing screw. Device was not in contact with patient. No patient injury/death was alleged or medical intervention was required. Patient was prepped for surgery. Delay in surgery was unknown.
 
Manufacturer Narrative
On 8/17/16 integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation results: failure analysis - a kerrison rongeur was returned with extreme wear, damaged screw on handle, repair markings on spring, dull tip and missing screw on top rail. Upon further investigation, it is noticed that the screw that is intact on the handle has been tampered with and the screw on the top rail is missing. This missing screw could have happened during sterilization/processing of the product and also not knowing the age or how the instrument was handled, could also have been a factor. The complaint report is confirmed. Device history evaluation - nonconforming product report / nonconforming material report history: none. Corrective action preventive action history/ correction: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there are no applicable engineering change order/ manufacturing change order history. Health hazard evaluation history: none. Conclusion: root cause has not been identified as a workmanship or material deficiency.
 
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Brand NameRUGGLES DIAMOND MEDIUM KERRISON RONGEUR - THIN F
Type of DeviceN/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 Key5880905
MDR Text Key53063275
Report Number2523190-2016-00131
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRD4824M
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2016
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 Reuse

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