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U.S. Department of Health and Human Services

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

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SYNTHES (USA) ROD, FIXATION INTRAMEDULLARY Back to Search Results
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.
 
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Type of DeviceROD, 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 Key6193483
MDR Text Key62953392
Report Number2520274-2016-15728
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/21/2016 Patient Sequence Number: 1
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