MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER; ROD,FIXATION,INTRAMEDULLARY

Model Number 03.037.024

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

The device was 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.

Event Description

It was reported that on (b)(6) 2018, while setting up the back table before a hip surgery procedure, there was an issue with the helical blade inserter for trochanteric fixation nail advanced (tfna).When the surgeon tried to enter the coupling screw, he was unable to screw it into the helical blade inserter itself.The coupling screw would screw into the lag screw inserter but would not engage in the helical blade inserter.A new set was opened to be used for the procedure.The issue was determined before the patient was in the room.There was no previous synthes hardware in the patient.The nonunion occurred after an attempt to treat the fracture nonoperatively.It is unknown if there was surgical delay.Procedure and patient outcome is unknown.Concomitant device reported: connecting/coupling screw(part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) helical blade inserter.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 on december 03, 2018, while setting up the back table before a hip surgery procedure, there was an issue with the helical blade inserter for trochanteric fixation nail advanced (tfna).When the surgeon tried to enter the coupling screw, he was unable to screw it into the helical blade inserter itself.The coupling screw would screw into the lag screw inserter but would not engage in the helical blade inserter.A new set was opened to be used for the procedure.The issue was determined before the patient was in the room.It is unknown if there was surgical delay.Procedure and patient outcome is 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.Part: 03.037.024; synthes lot: t112013; release to warehouse date: february 25, 2015; manufacture site: tuttlingen; part expiration date: n/a.Review of the device history records showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.No relevant nonconformance reports (ncrs) were generated during the production of this device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.Customer quality (cq) investigation: investigation flow: device interaction/functional.Visual inspection: the helical blade inserter was visually inspected, and the internal m9 thread form which mates with a helical blade coupling screw instrument shows post manufacturing damage.The most proximal thread form is deformed/dented which is related to the reported complaint condition.Unrelated to the reported complaint condition, the returned device was found to be missing the alignment indicator epoxy.The missing epoxy was investigated and does not require any additional investigation in this complaint investigation.Functional test: the helical blade coupling screw involved in the event was not returned and therefore a functional test was not able to be performed at cq.However, the damaged threads would contribute to the reported complaint condition.Does received condition agree with the complaint description? yes.Can the complaint be replicated with the returned device(s)? unable to perform.Device history record (dhr) review: the returned device was manufactured in february 2015.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.Document/specification review: the following design drawing(s) were reviewed during this investigation: tfna helical blade inserter assembly.Tfna helical blade inserter shaft component.The 03.037.024 helical blade inserter is a reusable instrument in the tfnadvanced proximal femoral nailing system.An 03.037.026 helical blade coupling screw instrument gets threaded into the 03.037.024 helical blade inserter which is then used to insert the helical blades.No design issues or deficiency was observed during the investigation.Dimensional inspection: dimensional analysis was not able to be performed on the internal m9 proximal thread form because it could not be accessed with a measurement device as it is located approximately 30mm distal to the proximal end.Was the complaint confirmed? yes.Investigation conclusion: the overall complaint condition is confirmed.While no definitive root cause could be determined, it is possible that the device encountered unintended forces such as attempted threading of a helical blade coupling screw into the device while not aligned with the thread.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.The missing epoxy was investigated and does not require any additional investigation in this complaint 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.

• Brand Name: HELICAL BLADE INSERTER
• 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: 8197612
• MDR Text Key: 131497561
• Report Number: 2939274-2018-55583
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070401
• UDI-Public: (01)10886982070401
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.024
• Device Catalogue Number: 03.037.024
• Device Lot Number: T112013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Date Manufacturer Received: 01/28/2019
• Patient Sequence Number: 1