MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 100MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.003.030S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 100mm-sterile.This is report 4 of 4 for (b)(4).
Event or Problem Description
Concomitant devices reported: unknown screws (part#unknown, lot# unknown, quantity# unknown).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: 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.

• Brand Name: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 100MM-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10214411
• Report Number: 2939274-2020-03032
• Device Sequence Number: 2095423
• Product Code: HSB
• UDI-Device Identifier: 10886982081643
• UDI-Public: (01)10886982081643
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 04.003.030S
• Device Catalogue Number: 04.003.030S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM; 9 MM / TI CANN FRN / GT 400MM / RIGHT - STERILE; 9 MM / TI CANN FRN / GT 420MM / LEFT - STERILE; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR