MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.126S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Event year is reported as 2020; however exact date of event is unknown.Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, 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 an unknown date, patient underwent removal of proximal femoral nailing system (tfna) nail that was broken after 6 months of implantation.Originally implanted with tfna nail, tfna blade and unknown locking screws on an unknown date.The fenestrated helical blade was intact, there was indentations on the blade due to the nail breaking around it.Fragments were completely removed.Removal was done fairly easily without significant intervention, then a total hip arthroplasty was completed.There was patient consequence reported.Concomitant device reported: unknown locking screw (part# unknown, lot# unknown, quantity 1).This complaint involves 2 devices.This report is for (1) 11mm/125 deg ti cann tfna 360mm/right - sterile.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- the 1mm/125 deg ti cann tfna 360mm/right - sterile (p/n: 04.037.126, lot number: unk) was received at us cq.Visual inspection of the complaint device showed the nail had broken at the proximal slot.Drill marks were observed inside the slot.This complaint is confirmed as the nail has broken at the proximal slot and shows drill marks.Pie has been launched to address the identified issue.The need for further corrective/preventive action will be assessed within the pie.Further investigation will not be conducted in this complaint as it will be addressed within pie no definitive root cause could be determined based on the provided information.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

• Brand Name: 11MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10311139
• MDR Text Key: 199988834
• Report Number: 2939274-2020-03276
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096401
• UDI-Public: (01)10886982096401
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.126S
• Device Catalogue Number: 04.037.126S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Date Manufacturer Received: 08/05/2020
• Patient Sequence Number: 1
• Treatment: TFNA FENESTRATED HELICAL BLADE 105MM - STERILE; UNK - SCREWS: LOCKING