MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.013.660S

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2022, a patient underwent a removal of nail and exchange with new nail due to new troch fracture.Two (2) screws were removed.One screw (1) was fund broken during removal procedure.It was noted that not all broken fragments were removed.Surgery was completed successfully without surgical delay.Patient outcome was unknown.This report is for one (1) 12mm ti cann retro/antegrade femoral nail-ex/400mm-sterile.This is report 1 of 2 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 # 04.013.660s, lot # 7509883, release to warehouse date: 07 nov 2013, expiration date: 30 sep 2022, supplier: (b)(4).Non-sterile: part # 04.013.660, lot # 7509883, release to warehouse date: 18 oct 2013, manufacturer: monument.A manufacturing record evaluation was performed for the non-sterile device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE
• 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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14253309
• MDR Text Key: 290448070
• Report Number: 2939274-2022-01567
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982088239
• UDI-Public: (01)10886982088239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 04.013.660S
• Device Catalogue Number: 04.013.660S
• Device Lot Number: 7509883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Sex: Female