MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.013.452S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Additional product code hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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, patient underwent removal of one (1) titanium retro/ antegrade femoral nail and four (4) titanium locking screws due to pain.Patient outcome was unknown.This complaint involves five (5) devices.This report is for (1) 10mm ti cann retro/antegrade femoral nail-ex/360mm-sterile.This is report 1 of 5 for (b)(4).

• Brand Name: 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE
• 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: 10843709
• Report Number: 2939274-2020-05154
• Device Sequence Number: 3931613
• Product Code: HSB
• UDI-Device Identifier: 10886982087874
• UDI-Public: (01)10886982087874
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.013.452S
• Device Catalogue Number: 04.013.452S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/16/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LCKN SCRW W/ T25 STRDRV 42MM FOR IM NALS
• Outcome Attributed to Adverse Event: Required Intervention