MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX; GUIDE

Model Number	03.010.052
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: visual inspection of the returned aiming revealed the thumb screw's dowel pin component had broken/sheared off flush with the surface of the knob's shaft component.The shaft was jammed within the aiming arm; the threads were not visible.The knob component was not returned.The device failure was identified; the complaint was confirmed.Dimensional inspection could not be performed due to the device's received condition.Document/specification review: the relevant drawings were reviewed (manufactured-to and current); no design issues were noted during investigation.Conclusion: the complaint was confirmed during investigation.No manufacturing issues were identified during investigation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A root cause could not be determined as the event conditions were unknown, however, it is possible the device and its components experienced abnormal forces during use and/or handling.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.A device history record (dhr) review was conducted: part: 03.010.052, lot: 1485408, manufacturing site: (b)(4), release to warehouse date: 23.May.2006.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 an unknown date, it was found out by the sterile processing department (spd) that the black knob on the aiming arm for the ex tibia nail set had come off.There was no patient involvement.During manufacturer's investigation on (b)(6) 2020 of the returned aiming, it was revealed that the thumb screw's dowel pin component had broken/sheared off flush with the surface of the knob's shaft component.This is report 1 of 1 for complaint (b)(4).

• Brand Name: AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9577018
• Report Number: 2939274-2020-00130
• Device Sequence Number: 3229526
• Product Code: FZX
• UDI-Device Identifier: 10886982067241
• UDI-Public: (01)10886982067241
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 11/12/2019

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: 03.010.052
• Device Catalogue Number: 03.010.052
• Device Lot Number: 1485408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1