MAUDE Adverse Event Report: SYNTHES TUTTLINGEN HELICAL BLADE INSERTER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.024

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: patient information not available for reporting.(b)(6).Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: manufacturing location: part 03.037.024 lot t114418; manufacturing date: 21-oct-2015.The lot t114418 was involved in a field investigation as potentially affected with a burr in the ø6.2 cannulation.The field investigation was closed with a decision of low or medium risk and no further actions required.The issue has no relevance to the complaint issue as the burr could only affect the helical blade coupling screw 03.037.026 from being inserted and would not affect the fit between the screw guide sleeve 03.037.017.Further review of the device history record in (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All (b)(4) parts of the lot were checked 100% for critical features and for function at the final inspection on 20-oct-2015.The ctq pin height was checked 100% on 14-oct-2015.No ncrs were generated during production.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 during a tfna (trochanteric fixation nail advanced) procedure on (b)(6) 2017, the helical blade inserter became stuck inside the blade/screw guide sleeve.The helical blade was fully inserted and both instruments performed as intended to successfully insert the helical blade.It was noted after the helical blade was inserted, the two devices could not be separated.The devices were removed from the patient and the surgeon continued the procedure without any surgical delay or additional medical intervention.The procedure was completed successfully and the patient status was reported as stable.After completion of the procedure, the two instruments were separated.This complaint involves two devices.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: product development investigation has been completed for part# 03.037.024, lot# t114418.A visual inspection, functional test, and device history records review were performed as part of this investigation.The returned helical blade inserter show some signs of wear but nothing that would impair their function.The reported devices function together as designed.Both devices are missing some small sections of colored epoxy, an issue being addressed.The proximal handle of the 03.037.024 inserter, a component that is disassembled for cleaning, was not returned with the device.No product design issues or discrepancies were observed.The cause of this complaint condition cannot be determined.The inserter was reported to have not released from the guide sleeve.This complaint is unconfirmed.The complaint condition cannot be replicated.The devices assemble and release as intended without difficulty.No design issue was found during the investigation of the inserter and guide sleeve.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): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6336076
• MDR Text Key: 67594861
• Report Number: 9680938-2017-10022
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070401
• UDI-Public: (01)10886982070401(10)T114418
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.024
• Device Lot Number: T114418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2017
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1