THIN OSTEOTOME HANDLE 242210000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-08 for THIN OSTEOTOME HANDLE 242210000 manufactured by Depuy Orthopaedics Inc Us.

MAUDE Entry Details

• Report Number: 1818910-2019-115378
• MDR Report Key: 9298150
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-11-08
• Date of Report: 2019-10-15
• Date of Event: 2019-01-01
• Date Mfgr Received: 2019-10-15
• Device Manufacturer Date: 2014-11-06
• Date Added to Maude: 2019-11-08
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KARA DITTY-BOVARD
• Manufacturer Street: 700 ORTHOPAEDIC DRIVE
• Manufacturer City: WARSAW IN 465810988
• Manufacturer Country: US
• Manufacturer Postal: 465810988
• Manufacturer Phone: 6107428552
• Manufacturer G1: DEPUY ORTHOPAEDICS, INC. 1818910
• Manufacturer Street: 700 ORTHOPAEDIC DR.
• Manufacturer City: WARSAW IN 465810988
• Manufacturer Country: US
• Manufacturer Postal Code: 465810988
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THIN OSTEOTOME HANDLE
• Generic Name: HIP INSTRUMENTS : HANDLES
• Product Code: HWM
• Date Received: 2019-11-08
• Catalog Number: 242210000
• Lot Number: VZ13293
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY ORTHOPAEDICS INC US
• Manufacturer Address: 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-08