MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.259S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Not available for reporting.Lot number not available for reporting.Implant date not available for reporting.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent a removal procedure on (b)(6) 2018.The patient was implanted with the trochanteric fixation nail advanced (tfna) nail and helical blade on an unknown date.Post-operatively, the patient experienced pain and the trochanteric fixation nail advanced (tfna) nail broke or snapped at the junction of the helical blade or bump cut in the nail.The nail was removed along with the blade and the patient's femur was then plated using the locking compression plate (lcp) proximal femur plate.Patient and surgical outcome are unknown.Concomitant devices reported: unknown screws (part# unknown, lot# unknown, quantity# unknown), tfna helical blade (part# 04.038.290s, lot # unknown, quantity# 1).This is report 1 of 1 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.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: 12MM/130 DEG TI CANN TFNA 380MM/LEFT-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: 7882992
• MDR Text Key: 120476288
• Report Number: 2939274-2018-53812
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097392
• UDI-Public: (01)10886982097392
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.259S
• Device Catalogue Number: 04.037.259S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention