MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER; ROD, FIXATION, INTRAMEDULLARY

Model Number 456.476S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Additional procode: hwc.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unavailable.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records 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 Description

It was reported that the patient underwent hip surgery on (b)(6) 2018.During the procedure, the helical blade did not pass through the trochanteric fixation nail system (tfn) on back table when testing the nail prior to insertion into patient.This resulted in the use of the tfn-advanced proximal femoral nailing system (tfna) intraoperatively.Postoperatively, the surgery team came to realize that out of the sterile packaging, the set screw was engaged too far into the nail, engaging the locking mechanism in the nail and preventing the helical blade from passing.The set screw needed to be dialed back a few turns in order the for the blade to pass.It is unknown if there was surgical delay.Patient outcome is unknown.Concomitant devices: tfn helical blade (part: unknown, lot: unknown, quantity: 1), trauma screw (part: unknown, lot: unknown, quantity: 1).This report is for a 12mm/130 deg titanium (ti) cann troch fixation nail 360mm/right-ster.This is report 1 of 1 for (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.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 patient underwent a hip surgery on (b)(6) 2018.During the procedure, the helical blade did not pass through trochanteric fixation nail (tfn) nail on the back table when testing the nail before insertion into patient.This resulted in the surgeon switching to the trochanteric fixation nail advanced (tfna) system for the procedure instead of the tfn system.Postoperatively, the surgery team came to realize that out of the sterile packaging, the set screw was engaged too far into the nail, engaging the locking mechanism in the nail and preventing the helical blade from passing.The set screw needed to be dialed back a few turns in order the for the blade to pass.It was unknown if there was surgical delay.Patient outcome was unknown.Concomitant device reported: helical blade (part# unknown, lot# unknown, quantity unknown), screws (part# unknown, lot# unknown, quantity unknown).

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.Additional narrative: device history record (dhr) review: item: 456.476s; lot: 9850781; mfg qty: 5; mfg date: 02 oct 2015; mfg location: monument; exp date: 31 aug 2024.Inspections performed per inspection sheets.Review of the sterility file showed that product was sterilized and passed all requirements.There were no ncs generated during the sterilization process.No relevant non-conformance to the complaint condition was identified.Review of dhr & scn files showed no non-conformances during manufacture that would contribute to complaint condition.Investigation summary: device evaluation: investigation flow: device interaction/functional visual inspection: the nail was received with the locking mechanism slightly advanced in the nail such that the tip of the locking prong is just visible in the proximal oblique locking hole.Slight wear was observed on the inner surfaces of the proximal oblique locking hole.No damage was observed on the locking mechanism.The balance of the device is in good condition with minimal wear.Functional test: testing with the mating device could not be completed as the mating helical blade was not received.Testing with gage pins was performed to simulate the mating helical blade.Per device drawing the mating helical blade has a 10.95mm +0.02/-0.03 outer diameter.The nail was found to only accept a 10.91mm gage pin in the received state.Thus, the mating helical blade would be expected to not assemble with the nail in the current state.Upon retraction of the locking mechanism, the nail was found to accept an 11.00mm gage pin and therefore would be expected to function with the mating device in this state.It was determined that the received condition does agree with the complaint description and can be replicated with gage pins.As reported, the set screw was engaged too far into the nail which would inhibit proper assembly with the mating device.Document/specification review: the device drawings reflecting the current and manufactured revision were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Dimensional inspection: the inner diameter of the proximal oblique locking hole, without the locking mechanism advanced, measured 11.00mm which is within the specification of 11.02mm +0.03/-0.02 [11.00-11.05] per device drawing.Measured using gage pins gp29 and gp32.Conclusion: the complaint condition is confirmed as the locking mechanism was advanced as reported.The received condition is consistent with inadvertent advancement of the locking mechanism such that it blocks a portion of the oblique hole.Thus, the root cause of the inability to advance the helical blade thought the nail is the result of the advanced locking mechanism.The root cause of the advanced locking mechanism could not be definitively determined as the circumstances surrounding the event and when the locking mechanism advanced are unknown.The titanium trochanteric fixation nail system technique guide dsus/trm/1115/0765(1) 4/17, notes that the locking mechanism is to be engaged after insertion of the head element.The guide also notes under the assemble insertion instruments step ¿to verify the appropriate position of the locking mechanism for the screw, pass the 5.0mm flexible hexagonal screwdriver though the cannulated connecting screw and turn counterclockwise until it stops.¿ the risk assessment was found to adequately address the complaint condition.No design or manufacturing defect or deficiency was observed during the investigation.No new malfunctions were observed during the course of this investigation.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.The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental 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/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER
• 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: 7626773
• MDR Text Key: 111938485
• Report Number: 2939274-2018-52580
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982228369
• UDI-Public: (01)10886982228369
• Combination Product (y/n): N
• PMA/PMN Number: K011857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 456.476S
• Device Catalogue Number: 456.476S
• Device Lot Number: 9850781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention