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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-09 for * manufactured by Synthes (usa) Products, Llc.

Event Text Entries

[4193135] While orthopedic surgeon was attempting to obtain bone biopsy, the trephine bone biopsy bit broke inside the patient. Surgeon was able to retrieve all pieces and confirm by x-ray there were no retained pieces.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3599021
• MDR Report Key: 3599021
• Date Received: 2014-01-09
• Date of Report: 2014-01-09
• Date of Event: 2014-01-03
• Report Date: 2014-01-09
• Date Reported to FDA: 2014-01-09
• Date Reported to Mfgr: 2014-01-30
• Date Added to Maude: 2014-01-30
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: BIOPSY BIT
• Product Code: MJG
• Date Received: 2014-01-09
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SYNTHES (USA) PRODUCTS, LLC
• Manufacturer Address: 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-01-09