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

Catalog Number 03.037.024

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 01/23/2016

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc.This report is for an unknown helical blade inserter/unknown lot.Part and lot numbers are unknown.Device has not been explanted yet.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during an insertion of a trochanteric fixation nail - advanced system (tfna) that the helical blade got halfway through the nail and would not advance or back out.It was noted that the set screw (the locking mechanism found inside the nail) migrated down slightly.It was unsure if the locking mechanism was the reason that the blade would not advance or back out.The surgeon tried to back out the helical blade with the extractor multiple times leading to a thirty to forty (30-40) minute surgical delay.While using the helical blade extractor to back out the helical blade, the tip of the extractor broke.Although the broken tip was retrieved, the blade was still stuck inside the patient.The locking mechanism was able to be removed and a new one was not implanted in its place.It was noticed that the lip of the locking mechanism was missing and it is unsure where the lip is.It was also noted that the helical blade inserter was not working correctly.Although the helical blade and the nail were left in the patient, the patient will need a revision surgery to either advance or remove the blade and the nail.It was additionally reported that although the nail and aiming arm were checked and noted to not have any issues with them, it is uncertain if they contributed to the product malfunctions noted in the procedure.It was reported that additional medical intervention (x-rays) were required and that additional blood may have been transfused.The patient status is stable (good) at this time but a revision surgery is required.This report is for an unknown helical blade inserter.This is report 4 of 6 for (b)(4).

Manufacturer Narrative

Product code hwc reported incorrectly; only product code should be lxh.Device is an instrument and is not implanted/explanted.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

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

This is report 3 of 8 for (b)(4).

Manufacturer Narrative

A product development evaluation was completed: the helical blade inserter (03.037.024) was received at the investigation site.Visual inspection reveals minor scratching along the shaft expected on a reusable instrument, but no damage which would prevent the instrument from functioning.The blade inserter assembles properly with the guide sleeve and coupling screw.Of the parts returned to the investigation site it appears that only the blade/screw extractor contributed to the helical blade removal difficulty described in the complaint.All other returned parts (insertion handle, aiming arm, blade inserter, cannulated connecting screw, helical blade coupling screw, and blade guide sleeve), assemble and function properly.They were part of the external construct during the procedure, but do not seem to have contributed to the complaint event, and their designs are found to be adequate.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

This is report 4 of 9 for (b)(4).

Manufacturer Narrative

Manufacturing date: june 25, 2015.Review of the device history records 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 material, components and final product met inspection records, certification test values and acceptance criteria.The pin and shaft raw materials are corresponding to the specifications.No non-conformance reports were generated during production.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

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 the 85 mm helical blade and the 11mm x 170mm nail are still implanted in the patient.The patient was reportedly fully healed and has requested the implants be removed but the removal procedure has not yet occurred.

• Brand Name: HELICAL BLADE INSERTER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen PA 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5440913
• MDR Text Key: 38315403
• Report Number: 2520274-2016-11067
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.024
• Device Lot Number: T115125
• Other Device ID Number: (01)10886982070401(10)T115125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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
• Patient Outcome(s): Required Intervention