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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: visual inspection: the tap for 2.0mm cortex screws 54mm was received at customer quality, and it was observed that the device was broken into two pieces along the threaded shaft.The threaded portion was the device was not returned to us cq.The complaint is confirmed.The device was broken into two pieces along the threaded shaft.Conclusion: the measuring result does show conformity.The diameter ø2.35 +0/- 0.016mm of the shaft got measured.Drawing: 2.0mm tap, 311_19 revision c, shaft diameter: ø2.35 +0/- 0.016mm, caliper: ca 215p, measured diameter = ø 2.34 mm.Conclusion: the measuring result does show conformity.The manufacturing record evaluation was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.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.Device history lot: part: 311.190, lot: 2726007, manufacturing site: (b)(4), release to warehouse date: jul 07, 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 (b)(6) 2019, a tap for cortex screws was noted to be broken during reverse logistics audit of the returned devices at millstone.There was no patient involvement.This is report 1 for 1 (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: 9186136
• Report Number: 2939274-2019-61511
• Device Sequence Number: 2460250
• 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: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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: 2726007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1