TROCHANTERIC NAIL KIT, STST GAMMA3? ?11X180MM X 130? 41301180S

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 2020-03-31 for TROCHANTERIC NAIL KIT, STST GAMMA3? ?11X180MM X 130? 41301180S manufactured by Stryker Trauma Kiel.

MAUDE Entry Details

• Report Number: 0009610622-2020-00137
• MDR Report Key: 9908201
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-03-31
• Date of Report: 2020-03-31
• Date of Event: 2020-03-05
• Date Mfgr Received: 2020-03-09
• Date Added to Maude: 2020-03-31
• 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: PHARMACIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. KEVIN SMITH
• Manufacturer Street: 325 CORPORATE DRIVE
• Manufacturer City: MAHWAH NJ 07430
• Manufacturer Country: US
• Manufacturer Postal: 07430
• Manufacturer Phone: 2018315000
• Manufacturer G1: STRYKER TRAUMA KIEL
• Manufacturer Street: PROF. KUENTSCHER-STRASSE 1-5
• Manufacturer City: SCHOENKIRCHEN/KIEL D-24232
• Manufacturer Country: DE
• Manufacturer Postal Code: D-24232
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TROCHANTERIC NAIL KIT, STST GAMMA3? ?11X180MM X 130?
• Generic Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Product Code: HSB
• Date Received: 2020-03-31
• Catalog Number: 41301180S
• Lot Number: KU115031
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER TRAUMA KIEL
• Manufacturer Address: PROF. KUENTSCHER-STRASSE 1-5 SCHOENKIRCHEN/KIEL D-24232 DE D-24232

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-31