MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 90MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.295S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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.A device history record review has been requested.(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, a patient was implanted with a trochanteric fixation nail advanced (tfna) during hip surgery.A follow up x-ray was done showing that the tfna helical blade had perforated the femoral head.Revision surgery to shorten the length of the tfna helical blade was performed on (b)(6) 2018.Patient status and procedure outcome are unknown.Concomitant device: tfna nail (part: unknown, lot: unknown, quantity: 1); locking screw (part: unknown, lot: unknown, quantity: 1) this report is for a tfna helical blade 95mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
This report is for a tfna helical blade 90mm.
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.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.Dhr review was completed.Part number: 04.038.290s.Lot number: h628637.Part manufacture date: 23 may 2018.Manufacturing location: elmira.Part expiration date: 30 april 2028.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows lot h628637 of ti helical blade 90mm-sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed raw material lot h606505 met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.Investigation flow: device interaction/functional.Visual inspection: visual inspection of the returned helical blade performed at customer quality (cq) identified normal wear associated with implantation and explantation.No abnormalities that would contribute to the reported complaint condition were observed.As no x-rays showing the reported condition of the helical blade perforating the femoral head were provided, the reported condition was not able to be confirmed.Functional test: a functional test /replication of the event is not applicable for this complaint condition.Dhr review: the returned device was manufactured in may 2018.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h628637 of ti helical blade 90mm-sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed raw material lot h606505 met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Document/specification review: design drawings were reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.Dimensional inspection: the diameter of the distal helix portion of the returned helical blade measured ø10.30mm at cq (calipers) which is within specification of ø10.3 +0/-0.1mm per tabulated design drawing.Risk documentation: this complaint condition is adequately covered by the risk assessment.Conclusion: a definitive root cause for the reported condition of the helical blade perforating the femoral head could not be determined based on the provided information.Per the event description " a revision surgery will be required to shorten the length of the tfna helical blade." it should be noted that the tfna helical blade is available in 5mm length increments.The reported complaint condition was not able to be confirmed and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation and this complaint condition is adequately covered by the risk assessment.No new, unique or different patient harms were identified as a result of this evaluation.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.

• Brand Name: TFNA HELICAL BLADE 90MM 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: 8015576
• Report Number: 2939274-2018-54663
• Device Sequence Number: 1382318
• Product Code: HSB
• UDI-Device Identifier: 10886982099013
• UDI-Public: (01)10886982099013
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.295S
• Device Catalogue Number: 04.038.290S
• Device Lot Number: H628637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/30/2018; 12/05/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 11/16/2018; 12/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention