MAUDE Adverse Event Report: SYNTHES HAGENDORF HELICAL BLADE/SCREW EXTRACTOR; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.037.030

Device Problem Break (1069)

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 extractor/unknown lot.Part and lot numbers are unknown; udi number is 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 extractor.This is report 3 of 6 for (b)(4).

Manufacturer Narrative

Product code hwc reported incorrectly; only product code should be hwb.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/screw extractor was received at the investigation site.Visual inspection reveals the fractured tip consistent with the complaint description.Additionally, the back of the device is deflected inward as if hit with a hammer.Finally, the silicone handle is gouged as if grasped by a toothed instrument.The gouges on the silicone handle as well as the break location could indicate that the instrument was used outside of its intended use.The deformation on the back of the instrument could indicate that the tool was hammered forward to seat into the helical blade.This may have been necessary, but if the surgeon was struggling to seat the screw, then it may not have been completely seated before the removal force was applied.Additionally, if the gouges and indentations on the silicone handle are from use with another instrument, the tool may have experienced bending instead of the tensile loading of backslapping, weakening the instrument.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), function and assemble 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 3 of 9 for (b)(4).

Manufacturer Narrative

Additional narrative: manufacturing location: (b)(4).Manufacturing date: may 19, 2015.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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/SCREW EXTRACTOR
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5440882
• MDR Text Key: 38313709
• Report Number: 2520274-2016-11066
• 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: 03.037.030
• Device Lot Number: 9376549
• Other Device ID Number: (01)10886982070463(10)9376549
• 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: 05/19/2015
• 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