MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TAP FOR 2.0MM CORTEX SCREWS 54MM; DRIVER,WIRE,BONE DRILL MANUAL

Model Number	311.19
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: investigation flow: damage.Visual inspection: the tap for 2.0mm cortex screws 54mm (p/n: 311.190, lot number: 2779963) was received at us cq.Upon visual inspection, the tap is broken at the first thread form.No other issues are identified.Device failure/defect identified? yes.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the tap is broken at the first thread form.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 311.190-exs.Lot: 2779963.Manufacturing site: bettlach.Release to warehouse date: dec.16, 2011.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 march 24, 2020, the two (2) taps for cortex screws were found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement.This complaint involves two (2) devices.This is report 2 of 2 for (b)(4).

• Brand Name: TAP FOR 2.0MM CORTEX SCREWS 54MM
• 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: 9968589
• Report Number: 2939274-2020-01886
• Device Sequence Number: 11324743
• Product Code: DZJ
• UDI-Device Identifier: 10886982187291
• UDI-Public: (01)10886982187291
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 311.19
• Device Catalogue Number: 311.19
• Device Lot Number: 2779963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/16/2020
• Patient Sequence Number: 1