MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TAP FOR 1.5MM CORTEX SCREWS 50MM; DRIVER,WIRE,BONE DRILL MANUAL

Model Number 311.15

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A product investigation was conducted.Visual inspection: the 1.5mm tap for 50mm cortex screws (part # 311.150, lot # 2542944) was received at us cq.Upon visual inspection, it was observed that the tap was broken at the first thread of the thread profile (proximal end).No other issues have been identified.Dimensional inspection: dimensional analysis was performed on the 1.5mm tap.Tap shaft diameter proximal to the broken thread profile was measured which falls within the specification per relevant drawing.Document/specification review: the following drawings were reviewed: 1.5mm tap (manufactured drawing).Tap for 1.5mm cortex screws 50mm.A review of the manufacturing record evaluations was performed for the finished device lot number, and no non-conformance's were identified.Conclusion: the complaint condition is confirmed for the tap for 1.5mm cortex screws 50mm (p/n 03.130.010 lot 2542944) as the tap was broken at the proximal end of the thread profile (first thread).During this investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.A device history record (dhr) review was conducted: part: 311.150.Lot: 2542944.Manufacturing site: bettlach.Release to warehouse date: 13.January 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on february 14, 2020, two (2) tap for cortex screws were discovered broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This report is for one (1) tap for 1.5mm cortex screws 50mm.This is report 1 of 2 for complaint (b)(4).

• Brand Name: TAP FOR 1.5MM CORTEX SCREWS 50MM
• Type of Device: DRIVER,WIRE,BONE DRILL MANUAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9950623
• MDR Text Key: 188215271
• Report Number: 2939274-2020-01799
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 10886982187284
• UDI-Public: (01)10886982187284
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 311.15
• Device Catalogue Number: 311.15
• Device Lot Number: 2542944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1