PINN POLY EXTRACTOR 2217-50-001 221750001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-29 for PINN POLY EXTRACTOR 2217-50-001 221750001 manufactured by Depuy Orthopaedics Inc Us.

MAUDE Entry Details

• Report Number: 1818910-2020-03440
• MDR Report Key: 9643289
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-01-29
• Date of Report: 2020-01-19
• Date of Event: 2020-01-01
• Date Mfgr Received: 2020-02-28
• Device Manufacturer Date: 2004-03-15
• Date Added to Maude: 2020-01-29
• 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 DR
• Manufacturer City: WARSAW IN 465810988
• Manufacturer Country: US
• Manufacturer Postal: 465810988
• Manufacturer Phone: 6107428552
• Manufacturer G1: JTE MANUFACTURING SITE
• Manufacturer Street: 700 ORTHOPAEDIC DR
• Manufacturer City: WARSAW IN 46581
• Manufacturer Country: US
• Manufacturer Postal Code: 46581
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PINN POLY EXTRACTOR
• Generic Name: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Product Code: HWB
• Date Received: 2020-01-29
• Model Number: 2217-50-001
• Catalog Number: 221750001
• Lot Number: J0304
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• 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		2020-01-29