MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 105MM; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.038.405

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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) 2021, the patient underwent for a tfna removal where the blade has migrated medial.It is unknown if the procedure was completed successfully.Patient status is unknown.Concomitant device reported: unk - locking screw (part#: unknown, lot#: unknown, quantity: 1).This complaint involves two (2) devices.This report is for (1) tfna fenestrated helical blade 105mm.This report is 2 of 2 of (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 105MM
• 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): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12647256
• MDR Text Key: 276883033
• Report Number: 2939274-2021-06140
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982099303
• UDI-Public: (01)10886982099303
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.405
• Device Catalogue Number: 04.038.405
• Device Lot Number: 42P0654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 10/130 DEG TI CANN TFNA 235/RIGHT - SILE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR