T-HANDLE BALL HEX SCREWDRIVER 8MM 03.010.517

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-22 for T-HANDLE BALL HEX SCREWDRIVER 8MM 03.010.517 manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

• Report Number: 2939274-2019-62346
• MDR Report Key: 9364255
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-11-22
• Date of Report: 2019-11-07
• Date of Event: 2019-11-07
• Date Mfgr Received: 2019-11-07
• Device Manufacturer Date: 2016-02-04
• Date Added to Maude: 2019-11-22
• 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: 1302 WRIGHTS LANE EAST
• Manufacturer City: WEST CHESTER PA 19380
• Manufacturer Country: US
• Manufacturer Postal: 19380
• Manufacturer Phone: 6103142063
• Manufacturer G1: SYNTHES HAEGENDORF GMBH-CN
• Manufacturer Street: IM BIFANG 6
• Manufacturer City: HAEGENDORF 4614
• Manufacturer Country: SZ
• Manufacturer Postal Code: 4614
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: T-HANDLE BALL HEX SCREWDRIVER 8MM
• Generic Name: HAMMER, SURGICAL
• Product Code: FZY
• Date Received: 2019-11-22
• Model Number: 03.010.517
• Catalog Number: 03.010.517
• Lot Number: 9786488
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WRIGHTS LANE SYNTHES USA PRODUCTS LLC
• Manufacturer Address: 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-22