MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.038.390

Device Problem Migration (4003)

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

Event Type  Injury  

Manufacturer Narrative

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.Product was not returned.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.(b)(4).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 removal of helical blade due to implant cutting out of femoral head.Removal had no incident and lag screw replaced the implant.Implant was discarded by facility.It is unknown if there was a surgical delay.Procedure outcome and patient status are unknown.Concomitant devices reported: unknown screw (part# unknown, lot# unknown, quantity unknown); unk - nails: tfna (part# unknown, lot# unknown, quantity 1).This report is for one (1) tfna fenestrated helical blade 90mm.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.H10 additional narrative: h6 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: TFNA FENESTRATED HELICAL BLADE 90MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12448946
• MDR Text Key: 270632048
• Report Number: 2939274-2021-05264
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982099242
• UDI-Public: 10886982099242
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.390
• Device Catalogue Number: 04.038.390
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: TFNA; UNK - SCREWS: LOCKING; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention