MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.003.029S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event occurred on an unknown date in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 returned to the operating room on (b)(6) 2020 for revision bilateral femur fractures.The patient had bilateral femoral roddings implanted on (b)(6) 2020.The left femoral rod required revision because the 6.5 mm titanium recon screws were too long and in the joint.The right femoral rod needed to be converted to a cephalomedullary nail due to an intertrochanteric fracture that was noticed postoperative.On the right side, all the hardware inserted on (b)(6) 2020 was removed with no complications.None of the hardware was broken.A long proximal femoral nailing system (tfna) with lag screw was implanted.On the left side, the two (2) 6.5 mm titanium recon screws were removed and replaced with shorter screws.Procedure and patient outcome were unknown.This complaint four (4) devices.This report is for one (1) 6.5mm ti recon screw with t25 stardrive 95mm-sterile.This is report 3 of 4 for (b)(4).

Event Description

Concomitant devices reported: unknown screws (part#unknown, lot# unknown, quantity# unknown).

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.H10 additional narrative: updated data-b5, h11.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.

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: d4.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: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM-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: 10214410
• MDR Text Key: 197142204
• Report Number: 2939274-2020-03031
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.003.029S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 07/17/2020; 07/24/2020
• Supplement Dates FDA Received: 07/23/2020; 08/03/2020
• Patient Sequence Number: 1
• Treatment: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 100MM.; 9 MM / TI CANN FRN / GT 400MM / RIGHT - STERILE.; 9 MM / TI CANN FRN / GT 420MM / LEFT - STERILE.; UNK - SCREWS: TRAUMA.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR