MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/420MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.013.864S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history lot: manufacturing location: (b)(4).Manufacturing date: 25-feb-2011.Expiration date: 31-jan-2020.Part number: 04.013.864s, 14mm ti cann retro/antegrade femoral nail-ex/420mm ¿ sterile; lot number: 6599813 (sterile).Component part(s) reviewed: part number: 21014, tialnbri16.00; lot number: 6204495.Product traveler met all inspection acceptance criteria.Product certification supplied by dynamet dated 31-jul-2009 was reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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, the patient underwent removal of hardware due to nonunion.The patient had malunion distal femur with modified expert retrograde anterograde femoral nail (ex rafn).The patient was implanted with the following devices; one (1) ex rafn nail, two (2) unknown 6.0mm screw, one (1) unknown 5.0mm screw, one (1) unknown spiral blade, one (1) unknown end cap on (b)(6) 2018.The ex rafn was modified by the surgeon from the previous procedure by drilling 5.0mm hole into the shaft of nail for a 5.0mm screw for a bone transport procedure.The reamer irrigation aspirator (ria) was used to harvest bone graft.It was revised to a 4.5mm variable angle locking compression plate (va lcp) condylar plate with articulating tension device and 3.5/4.5mm lcp metaphyseal plate.It was unknown if there was a surgical delay.Procedure was successfully completed.Patient outcome is unknown.This report is for one (1) 14mm ti cann retro/antegrade femoral nail-ex/420mm-sterile.This is report 1 of 6 for (b)(4).

• Brand Name: 14MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/420MM-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: 8934649
• Report Number: 2939274-2019-60110
• Device Sequence Number: 617788
• Product Code: HSB
• UDI-Device Identifier: 10886982088581
• UDI-Public: (01)10886982088581
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

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 Expiration Date: 01/31/2020
• Device Model Number: 04.013.864S
• Device Catalogue Number: 04.013.864S
• Device Lot Number: 6599813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR