MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/340MM-STERILE; ROD,FIXATION, INTRAMEDULLARY

Model Number	04.013.648S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code hwc.Investigation summary.Part number: 04.013.648s, 12mm ti cann retro/antegrade femoral nail-ex/340mm ¿ sterile; lot number: 6491730 (sterile); manufacturing location: (b)(4); manufacturing date: 05-oct-2010; expiration date: 30-aug-2019; lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance, met all inspection acceptance criteria.Inspection sheet, inspect dimensional, met all inspection acceptance criteria.Inspection sheet, final inspection, met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and all components issued met current defined requirements.Scn 7130 supplied by sterigenics was reviewed and determined to be conforming.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.Component part(s) reviewed: part number: 21012, tialnbri13.00; lot number: 6287228; lot quantity: 1,988 lbs.Product certification supplied by dynamet dated 19-nov-2009 was reviewed and determined to be conforming.Surgical/ medical intervention; revision surgery.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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, a patient underwent removal of nail due to nonunion and delayed healing.All hardware was intact.Patient was revised to a plate.It was noted patient poor bone quality and fracture pattern.Procedure was successfully completed with no surgical delay.No patient consequence.This is report 1 of 6 for (b)(4).

• Brand Name: 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/340MM-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: 8940234
• Report Number: 2939274-2019-60152
• Device Sequence Number: 18888882
• Product Code: HSB
• UDI-Device Identifier: 10886982088208
• UDI-Public: (01)10886982088208
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/31/2019

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: 08/30/2019
• Device Model Number: 04.013.648S
• Device Catalogue Number: 04.013.648S
• Device Lot Number: 6491730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR