MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON EXPRESS CURETTE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	A13A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis results: visual optical visual and optical examination of the distal tip of the instrument identified shaft fracture at the welded portion of the tip.The cannula is still attached to the curette.It appears the tip is damaged not allowing the cannula to slide off.This type of damage is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent spinal surgery due to metastatic disease in spine.Intra-op, currette was used by the surgeon to scrap and score sclerotic bone, but it had stuck in patient's body.The surgeon had worked hard to get it come out of the body, but the surgeon failed to remove it, and finally used cannula to pull it out.Tip of the currette has been broken off.

• Brand Name: KYPHON EXPRESS CURETTE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8402754
• Report Number: 9612164-2019-00812
• Device Sequence Number: 2054132
• Product Code: LXH
• UDI-Device Identifier: 00643169097223
• UDI-Public: 00643169097223
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2019
• Device Catalogue Number: A13A
• Device Lot Number: WI535829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1