MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC GUIDE WIRE AIMING DEVICE F/TFN FOR ANT POSTERIOR ORIENTATION

Model Number	03.010.412
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, during intra-operative surgery, the trochanteric fixation nail set was found broken.This included the helical blade coupling screw, deg aiming arm trochanteric fixation nails, and helical blade inserter.The procedure was successfully completed.There was no patient consequence.This report is for one (1) guide wire aiming device f/tfn for ant posterior orientation this is report 4 of 4 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h4, h6: a device history record (dhr) review was conducted: part: 03.010.412.Lot: 09b8022.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 18.Mar.2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The raw material was confirmed to be correct per the specification with no non-conformance noted.H3, h6: a product investigation was conducted.Visual inspection: upon visual inspection, it was observed that the guide wire aiming device f/tfn for ant posterior orientation was cracked where it articulates to the aiming arm.The fracture runs through the left hole for the alignment pin which was found to be missing.The received condition of the device was determined to agree with the complaint description.The cause of the issue could not be determined.Dimensional inspection: due to post-manufacturing damage, dimensional inspection could not be conducted.Document/specification review: during the document/specification review the relevant drawings, reflecting the current and manufactured revision, were reviewed.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The raw material was confirmed to be correct per the specification with no non-conformance noted.The complaint condition was determined to be confirmed based on the visual inspection.Investigation conclusion: the complaint condition was confirmed as the guide wire aiming device was observed to be broken where it articulates with the aiming arm.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H11 corrected data: g1 physical manufacturer.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.

• Brand Name: GUIDE WIRE AIMING DEVICE F/TFN FOR ANT POSTERIOR ORIENTATION
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8336478
• Report Number: 2939274-2019-56437
• Device Sequence Number: 19214266
• Product Code: FZX
• UDI-Device Identifier: 10886982068583
• UDI-Public: (01)10886982068583
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 01/23/2019

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: 03.010.412
• Device Catalogue Number: 03.010.412
• Device Lot Number: 09B8022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1