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

Model Number	04.038.395
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: ktt.Reporter is company representative the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 trochanteric femoral nail advanced (tfna) blade has penetrated medially to the femoral head as confirmed by x-rays taken on an unknown date.The patient outcome is unknown.Concomitant devices reported: unknown tfna nail (part # unknown, lot # unknown, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity 1), unknown end cap (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This is report 1 of 1 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.H6: code 3191 used to capture surgical intervention and surgical intervention.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.
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.H3, h6: reviewing attached x-ray, the complaint description can be confirmed that the tfna blade has penetrated medially to the femoral head.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.
Event or Problem Description
It was reported that on an unknown date, the trochanteric femoral nail advanced (tfna) blade had penetrated medially to the femoral head as confirmed by x-rays taken on an unknown date.The patient walked into the office with a walker and no signs of pain.The revision surgery was done on (b)(6) 2020.The patient outcome is unknown.Concomitant devices reported: unknown tfna nail (part# unknown, lot# unknown, quantity 1, unknown locking screw (part# unknown, lot# unknown, quantity 1, unknown end cap (part# unknown, lot# unknown, quantity 1.This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 95MM
• 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: 10027050
• Report Number: 2939274-2020-02264
• Device Sequence Number: 3117017
• Product Code: HSB
• UDI-Device Identifier: 10886982099266
• UDI-Public: (01)10886982099266
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.395
• Device Catalogue Number: 04.038.395
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 05/07/2020; 05/14/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/08/2020; 05/26/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED HELICAL BLADE 95MM; UNK - END CAPS: TFNA; UNK - NAILS: TFNA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Weight: 73