G7 STR INSRTR THREADED SHAFT N/A 110003452

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-10-09 for G7 STR INSRTR THREADED SHAFT N/A 110003452 manufactured by Zimmer Biomet, Inc..

MAUDE Entry Details

• Report Number: 0001825034-2019-04544
• MDR Report Key: 9171600
• Report Source: DISTRIBUTOR,HEALTH PROFESSION
• Date Received: 2019-10-09
• Date of Report: 2019-10-08
• Date of Event: 2019-09-18
• Date Mfgr Received: 2019-09-18
• Device Manufacturer Date: 2015-08-17
• Date Added to Maude: 2019-10-09
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. CHRISTINA ARNT
• Manufacturer Street: 56 E. BELL DR.
• Manufacturer City: WARSAW IN 46582
• Manufacturer Country: US
• Manufacturer Postal: 46582
• Manufacturer Phone: 5745273773
• Manufacturer G1: ZIMMER BIOMET, INC.
• Manufacturer Street: 56 E. BELL DRIVE
• Manufacturer City: WARSAW IN 46582
• Manufacturer Country: US
• Manufacturer Postal Code: 46582
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: G7 STR INSRTR THREADED SHAFT
• Generic Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Product Code: OQI
• Date Received: 2019-10-09
• Returned To Mfg: 2019-09-20
• Model Number: N/A
• Catalog Number: 110003452
• Lot Number: 427424
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER BIOMET, INC.
• Manufacturer Address: 56 E. BELL DRIVE WARSAW IN 46582 US 46582

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-09