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

Model Number 04.038.190

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional device product code: ktt.(b)(4).The device has been 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 october 22, 2020, the patient underwent removal of a proximal femoral nailing system (tfna) due to tfna fenestrated screw broke in the thread.During the procedure the tfna nail, fenestrated screw and a distal locking screw were removed successfully without further damage and the patient was revised to a bipolar hip.The femur split during implantation of bipolar hip and a cerclage cable was used to stabilize the femur and implant.The procedure was successfully completed.The patient's status is unknown.Concomitant device reported: tfna nail (part #: 04.037.242, lot #: h607959, quantity: 1), unknown locking screw (part #: unknown, lot #: unknown, quantity: 1).This report is for one (1) tfna fenestrated screw 90mm.This is report 1 of 1 for complaint (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.H3, h4, h6: part 04.038.190, lot 17p3920: manufacture date: september 17, 2019.Manufacturing location: elmira.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H3, h6: a product investigation was completed: visual inspection of the complaint device showed the distal end (threads) had broken.No dimensional inspection can be performed due to post manufacturing damage.The current and manufacturer to drawings were reviewed; no design issues or discrepancies were identified.This complaint is confirmed as the distal end of the device has broken.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: TFNA FENESTRATED SCREW 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: 10869471
• MDR Text Key: 217161609
• Report Number: 2939274-2020-05235
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098726
• UDI-Public: (01)10886982098726
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.190
• Device Catalogue Number: 04.038.190
• Device Lot Number: 17P3920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 12/08/2020
• Patient Sequence Number: 1
• Treatment: 12MM/130 DEG TI CANN TFNA 170MM - STERILE; UNK - SCREWS: LOCKING; 12MM/130 DEG TI CANN TFNA 170MM - STERILE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Weight: 85