MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 95MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.295S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, on an unknown date, the patient underwent revision surgery of the hip due to implant failure and failure to heal.The reason for the failure to heal is unknown.The failed implant involved trochanteric femoral nailing advanced proximal femoral nailing system (tfna) nail, tfna- helical blade, and unknown locking screws which were removed and replaced.The surgeon inserted a new tfna nail and tfna-titanium cannulated screw in place of the helical blade.It was the surgeon's preference to replace the helical blade with the screw.According to the surgeon, there were no obvious errors in the original surgery or implant.The surgical procedure was completed successfully.The patient outcome is unknown.This report is for one (1) tfna helical blade 95mm sterile.This is report 2 of 3 for (b)(4).
Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: 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.

• Brand Name: TFNA HELICAL BLADE 95MM 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: 7947127
• Report Number: 2939274-2018-54259
• Device Sequence Number: 19397030
• Product Code: HSB
• UDI-Device Identifier: 10886982099013
• UDI-Public: (01)10886982099013
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 04.038.295S
• Device Catalogue Number: 04.038.295S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 10/12/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention