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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SELZACH UTN Ø8 L330 CPL W/END CAP SST; NAIL, FIXATION, BONE

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SYNTHES SELZACH UTN Ø8 L330 CPL W/END CAP SST; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 278.630
Device Problem Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 09/30/2015
Event Type  Injury  
Manufacturer Narrative
Device became stuck intra-op and therefore was not implanted / explanted.(b)(6).(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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
Device report from synthes (b)(6) reports an event in france as follows: during implementation of the left tibia nailing surgery a nail reportedly broke.The surgeon was able to remove the nail due to total blocking of the nail fixing part with its ancillary and after the final lock and reamed intramedullary canal, thereafter the surgeon used a larger diameter nail (9).Upon receipt of the nail, it was found that the thread of the connecting screw is broken off and is stuck in the nail.The nail was found to be intact and was not broken.This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
Device history record review: manufacturing location: (b)(4) - manufacturing date: february 13, 2015.No anomalies were detected during device history record review.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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
Additional narrative: product investigation summary: the connecting screw was found broken at the outside thread.The first 10-15mm of the screw were broken and still jammed in the nail.Furthermore, marks and nicks were discovered at the knurled surface.There are marks of forcible and inadequate use at the head of the nail.A forceps or similar instrument was certainly used on the implant.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Because of the various signs of damage on the connecting screw, it is likely that the threaded part was not inserted/aligned correctly into the nail.Also, during the screwing portion of the procedure, there were likely high applied mechanical forces on the connecting screw which could cause the complained issue.The complaint relevant dimensions were checked, as far as possible, and found to be in compliance with specifications.The microscopic view of the broken surface does not show any anomalies, which indicates material conformity to the specifications.Based on the investigation results, the cause of failure is not due to any manufacturing non-conformances.No product fault could be detected.Device 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.
 
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Brand Name
UTN Ø8 L330 CPL W/END CAP SST
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ  CH2545
Manufacturer (Section G)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ   CH2545
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5204389
MDR Text Key30495554
Report Number3009417901-2015-10028
Device Sequence Number1
Product Code JDS
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 Physician
Type of Report Initial,Followup,Followup
Report Date 10/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number278.630
Device Lot Number5932921
Other Device ID Number(01)07611819012370(10)5932921
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/23/2015
Initial Date FDA Received11/05/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received11/24/2015
12/17/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2015
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
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