MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FOR EXPERT ALFN/100MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	03.010.488
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on an unknown date, the driving caps and insertion handles were discovered to be broken in sterile processing department (spd).They belong in the adolescent lateral femoral nail (alfn) insertion set.There was no patient involvement.This complaint involves two (2) devices.This report is 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: h3, h4, h6: part 03.010.488, lot 8813578: manufacturing site: hägendorf.Release to warehouse date: march 07, 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: the returned insertion handle was visually inspected, and no broken portion was identified.It should be noted that the broken tip from the driving cap was lodged inside this device.As no defect was found during investigation, the reported complaint cannot be confirmed.A visual inspection was performed as part of the investigation and found that there are no defects as reported in the complaint.Thus, complaint was not confirmed.Based upon these results, 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 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: RADIOLUCENT INSERTION HANDLE FOR EXPERT ALFN/100MM
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8356411
• Report Number: 2939274-2019-56555
• Device Sequence Number: 1697745
• Product Code: HSB
• UDI-Device Identifier: 10886982069061
• UDI-Public: (01)10886982069061
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K070843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2019

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: 03.010.488
• Device Catalogue Number: 03.010.488
• Device Lot Number: 8813578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/19/2019
• Patient Sequence Number: 1