MAUDE Adverse Event Report: SYNTHES (USA); ROD, FIXATION INTRAMEDULLARY

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for one unknown pfna nail, unknown lot number.Udi: unknown part number, udi is unavailable.Device was implanted in 2015.Exact date is unknown.An attempt was made to explant the device however, it was unsuccessful.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that a removal surgery for proximal femoral nail antirotate (pfna) material was performed.Patient was implanted with a pfna nail and blade in 2015 in (b)(6) due to an accident.Exact date of implantation is unknown.A removal procedure was attempted in (b)(6) of 2016 at another hospital.Reason for removal is unknown.Removal surgery was unsuccessful.Patient returned for a second attempt on (b)(6) 2016.The connection of the tools present in the set was not possible.The extraction clamp was not very powerful.Unknown quantities of high speed steel (hss) drills and carbide were used for the removal of the blade but were unsuccessful.After two (2) hours of intervention, the surgeon decides to leave the implants in place.The patient will leave the hospital with his implants.If patient later needs prosthesis, this may be a problem.First removal surgery attempt in (b)(6) of 2016 was captured in complaint (b)(4).This report is for one unknown pfna nail.This is report number 1 of 5 for complaint (b)(4).

Manufacturer Narrative

Describe event or problem: additional information.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

The surgeon tried to remove the blade from the patient.He was unable to remove the blade because there was an earlier attempt on another establishment the previous surgeon had to force on it and blocked the body of the blade in the pfna.Moreover, the thread of the blade has been damaged by the previous surgeon and neither the hooks nor the blade extractors have made it possible to remove.The kit returned to the technicians and they detected a damaged adapter with thread for blade removal.Concomitant reported part: hook (quantity 1), extraction clamp (quantity 1).This is report 1 of 6 for (b)(4).

Manufacturer Narrative

Patient height reported as (b)(6).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

Patient was active and athletic.The removal surgery was a planned surgery.This ablation seemed legitimate to the surgeon given the age of the patient and the possibility that he could one day benefit from total hip prosthesis or a total knee prosthesis, or even in case of new traumatism on this member.

Manufacturer Narrative

Additional narrative: device was implanted in 2012.Exact date is unknown.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

The thread of the blade stopper screw, which is the component of the blade was broken.Attempt of extraction of the stopper with various ancillary threaded extractors and special pliers for difficult extraction.In view of the impossibility to mobilize the stopper, it was decided to perforate it using tungsten carbide drills.After use of one tungsten carbide drill with a diameter of 6 mm and one with a diameter of 4 mm, they ablated the stopper.Attempt of extraction of the socket according to the operating technique.Despite multiple attempts with help of blade extraction pliers, a threaded adaptor for blade extraction, socket and blade extractor, no blade or socket mobilization was possible.Attempt of extraction of the blade with a dedicated hook under arthroscopic control.The blade did not move either.A new attempt of drilling to detach the socket from the blade and extract the internal screw of the blade.Continuous cooling by irrigation during the drilling phase.Despite the use of 7 other tungsten carbide drills, it was impossible to extract the equipment.In view of the impossibility to extract the material, decision was taken to end the intervention.

• Type of Device: ROD, FIXATION INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6193483
• MDR Text Key: 62953392
• Report Number: 2520274-2016-15728
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 80