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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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).Broken thread component was not returned for the investigation.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.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.Jan.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 or Problem 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 2 of 2 for complaint (b)(4).

• Brand Name: TAP FOR 1.5MM CORTEX SCREWS 50MM
• Common Device Name: DRIVER,WIRE,BONE DRILL MANUAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9950619
• Report Number: 2939274-2020-01801
• Device Sequence Number: 3271596
• Product Code: DZJ
• UDI-Device Identifier: 10886982187284
• UDI-Public: (01)10886982187284
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K150796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1