MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC Ø8.2MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/380MM/LT; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.031.939

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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 Description

It was reported that on (b)(6) 2019, the patient underwent removal and revision of titanium adolescent lateral femoral nail and unknown screws due to nonunion.Implants were originally implanted on (b)(6) 2019.The surgeon used the saw blade through the nonunion site and ream femur.Application of plate and six (6) cortex screws.The procedure was successfully completed.The patient outcome was unknown.This complaint involves three (3) devices.This report is for one (1) ø8.2 mm ti adolescent lat entry femoral nail-ex/380 mm/ lt.This is report 3 of 3 for (b)(4).

• Brand Name: Ø8.2MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/380MM/LT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9530667
• MDR Text Key: 173076258
• Report Number: 2939274-2019-62795
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819310391
• UDI-Public: (01)07611819310391
• Combination Product (y/n): N
• PMA/PMN Number: K070843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.031.939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention