MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.228S

Device Problem Break (1069)

Patient Problems Death (1802); Failure of Implant (1924)

Event Type  Death  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 the patient underwent hardware removal on an unknown date due to the broken implanted long right trochanteric femoral nail advance (tfna) nail which failed at the helical blade site.The broken implants were removed without issue or further consequence to the patient.X-ray was taken intraoperatively proving removal of all implants.Surgical procedure was successfully completed.Patient outcome is unknown.Concomitant device reported: helical blade (part #:04.038.290s, lot#: h279255, quantity #1), unknown locking screw (part unknown, lot unknown, quantity #1).This report is for one (1) 12mm/125 deg ti cann tfna 380mm/right - sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.(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 Description

Hardware removal occurred on (b)(6) 2018.Patient died on (b)(6) 2018.Concomitant devices: helical blade (part: 04.038.290s, lot: h279255, quantity: 1), 5.0mm titanium (ti) locking screw 38mm (part: 04.005.528, lot: unknown, quantity: 1), 5.0mm ti locking screw 40mm (part: 04.005.530, lot: unknown, quantity: 1).

Manufacturer Narrative

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

Updated event description: it was reported that the patient underwent hardware removal on (b)(6) 2018 due to the broken implanted long right trochanteric femoral nail advance (tfna) nail that failed at the helical blade site.The broken implants were removed without issue or further consequence to the patient.The original surgery took place on (b)(6) 2017.X-ray was taken intraoperatively proving removal of all implants.The procedure was successfully completed with unknown surgical delay.The patient merely stood up from a seated position causing immediate right hip pain.The hip failed on or about (b)(6) 2018 resulting in a hospitalization on (b)(6) 2018.The patient developed severe sepsis causing her death on or about (b)(6) 2018.

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 awareness date reported on follow up 5 report as november 06, 2018 but should have been november 06, 2019.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.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.Device evaluated by mfr: manufacturing location: monument; manufacturing date: april 22, 2016; expiration date: march 31, 2026; part: 04.037.228s; 12mm/125 deg ti cann tfna 380mm/right- sterile; lot: h085574 (sterile); lot quantity: 4 work order traveler met all inspection acceptance criteria.Two pieces were scrapped in qa final inspect for burrs in inner diameter.Inspection sheet, in-process/inspect dimensional/final met all inspection acceptance criteria apart from the two pieces noted.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) 12454 supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: part: 04.037.912.2; lock prong, 125 degree, tfna, bp55; lot: 9822917; lot quantity: 96 work order traveler met all inspection acceptance criteria.Part: 04.037.912.4; wave spring, shim ended, bp55; lot: 9850940; lot quantity: 1,005 work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley were reviewed and determined to be conforming.Part: 04.037.912.3; tfna lock drive, bp58; lot: h069300; lot quantity: 80 work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part: 21127; timoagri16.00, bp80; lot: 9980176; lot quantity: 1,523 lbs.Certificate of test received from ati specialty metals was reviewed and determined to be conforming.Lot summary report dated met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Us customer quality (cq) returned product investigation flow: broken.Visual inspection: the nail was received at us cq broken at the head element hole.The received condition agreed with the complaint description.The complaint was confirmed during investigation.No other damage was noted besides wear consistent with implantation and explantation to either the returned nail or concomitant helical blade (04.038.290, lot h279255).Dimensional inspection: dimensional inspection of the returned device could not be performed due to the received condition of the device.Document/specification review: the following drawings were reviewed: tfna 125-degree assembly drawing tfna 12mm nail tabulated drawing during the investigation, no product design issues were observed that may have contributed to the complaint condition.Device history record (dhr) review: review of the device history record(s) showed that the lot went through the required steps during the inspection at the time of manufacturing and showed no issues concerning the material or material conditioning.Risk documentation review: the "trochanteric fixation nail ¿ advanced" design and clinical risk management document was reviewed.Review found that the complaint is adequately addressed by the risk assessment.Conclusion: the complaint condition was confirmed.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A root cause could not be determined as the event conditions were unknown; however, it is likely the device experienced extreme forces while implanted.The complaint condition is adequately addressed by the risk assessment.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.Patient¿s height reported as 158.00 cms.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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/125 DEG TI CANN TFNA 380MM/RIGHT - 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: 7942421
• MDR Text Key: 123062763
• Report Number: 2939274-2018-54210
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097149
• UDI-Public: (01)10886982097149
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.228S
• Device Catalogue Number: 04.037.228S
• Device Lot Number: H085574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Date Manufacturer Received: 12/02/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Weight: 70