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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES HAGENDORF COMPLETE RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY

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SYNTHES HAGENDORF COMPLETE RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.012
Device Problem Failure to Align (2522)
Patient Problems Sedation (2368); No Code Available (3191)
Event Date 01/23/2016
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown insertion handle/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4) additional x-rays.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 insertion handle.This is report 7 of 8 for (b)(4).
 
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 7 of 8 for (b)(4).
 
Manufacturer Narrative
A product development evaluation was completed: the insertion handle (03.037.012) was received at the investigation site.Visual inspection reveals minor scratching on the part expected on a reusable instrument, but no damage which would prevent the instrument from functioning.The insertion handle assembles properly with the aiming arm and connecting 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 7 of 9 for (b)(4).
 
Manufacturer Narrative
Manufacturing location: (b)(4).Manufacturing date: august 03, 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.
 
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Brand Name
COMPLETE RADIOLUCENT INSERTION HANDLE
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 Key5444464
MDR Text Key38463569
Report Number2520274-2016-11130
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK131548
Number of Events Reported1
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 Received02/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.037.012
Device Lot Number9501837
Other Device ID Number(01)10886982070289(10)9501837
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received04/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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