2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING 45-20001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING 45-20001 manufactured by Stryker Gmbh.

MAUDE Entry Details

• Report Number: 0008031020-2020-00881
• MDR Report Key: 9891716
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-03-27
• Date of Report: 2020-03-27
• Date of Event: 2020-02-11
• Date Mfgr Received: 2020-03-03
• Device Manufacturer Date: 2014-09-03
• Date Added to Maude: 2020-03-27
• 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: MR. SHARON RIVAS
• Manufacturer Street: 325 CORPORATE DRIVE
• Manufacturer City: MAHWAH NJ 07430
• Manufacturer Country: US
• Manufacturer Postal: 07430
• Manufacturer Phone: 2018315000
• Manufacturer G1: STRYKER LEIBINGER FREIBURG
• Manufacturer Street: BOETZINGERSTR. 41
• Manufacturer City: FREIBURG D-79111
• Manufacturer Country: DE
• Manufacturer Postal Code: D-79111
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING
• Generic Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Product Code: LXH
• Date Received: 2020-03-27
• Returned To Mfg: 2020-02-17
• Model Number: 45-20001
• Catalog Number: 45-20001
• Lot Number: AE11
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER GMBH
• Manufacturer Address: BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-27