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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MEZZOVICO USS-II NUT TAN GREEN APPLIANCE,FIXATION,SPINAL

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SYNTHES MEZZOVICO USS-II NUT TAN GREEN APPLIANCE,FIXATION,SPINAL Back to Search Results
Catalog Number 499.294
Device Problem Break (1069)
Patient Problems Sedation (2368); No Code Available (3191)
Event Date 01/25/2017
Event Type  Injury  
Manufacturer Narrative
Device used for treatment, not diagnosis. Additional product codes: mni, mnh, kwp, kwq. Implanted/explanted on the same day. (b)(4): the complaint indicated that the polyaxial sleeve broke during surgery. There were no reports of fragments left in patient. Because the implant became unsuccessful, the surgeon explanted it on the same day and the surgeon had to re-open the incision in order to remove the screw unit. There was approximately 120 minute surgical delay due to device malfunctions. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Dhr review for part # 499. 294 / l116830; manufacturing location: (b)(4); manufacturing date: 30 august 2016. No ncrs 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. 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 on an event in (b)(6) as follows: the reported products were used during the screw replacement surgery after the incident (b)(4) on (b)(6) 2017. In order to replace the migrated screw, described on (b)(4), the surgeon provided the remobilization tool to unlock uss-ii (universal spinal system) polyaxial sleeve and uss-ii nut. Because the t-shaped handle became immobilized, he could not turn it both clockwise and counterclockwise. After several trials, the sleeve and the nut were broken, he re-opened the incision and tried the explant of the screw unit. However, the unit broke. He removed the rod and finally removed the screw unit. It took approximately 100 minutes to remove the screw. Because the exact specifications of the broken screw was not available, he chose a replacement, which had the same thickness but one size shorter. It took approximately 20 minutes to insert the replacing screw. There is no information available about patient and surgical outcome. There was a surgical prolongation of 120 minutes reported. No fragments were generated. This complaint involves 6 parts. Concomitant device: 1x unk screw. This report is 2 of 2 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. A manufacturing investigation was performed for the subject device uss-ii nut tan green, part number 499. 294, lot number l116830. The subject device was returned with the complaint condition stating: according to the complaint description, after several trials the sleeve and the nut were broken. Three components (lot#9903048, l074114 and 9886436) are seriously damaged post production and of these the sleeve item lot#l074114 is broken and the nut item lot#9903408 is blocked on the head component lot#9886436 (the nut is not broken differently from the complaint description). Two items (lot#l074095 and lot#l116830) are not damaged. The broken sleeve item lot#l074114 has been manufactured starting from raw material lot#(b)(4). The certificate of the raw material lot#(b)(4) was reviewed. In the certificate it is reported that the material fulfills the specification. The returned parts were re-inspected for all the features pertinent to the complaint condition. Among the five received components, two components re-inspected result dimensionally conforming to specs and the remaining 3 assembled components were seriously damaged post production and so not measurable. For the damaged components it is possible to state that the pieces have not been assembled/handled post production in the correct way: no manufacturing related nonconformance have been identified. Considering that all relevant measurable product features meet specification and no visual defects manufacturing related have been identified on returned items, the conclusion of the product investigation is that the returned parts are conforming from a manufacturing perspective. Mia is disposed as confirmed due to the evidence that the sleeve is broken, but it is not valid for (b)(4) because no manufacturing related issue was identified. No manufacturing related issue was identified, therefore review to the specific prm and prm line is not applicable. Parts returned to customer quality as per procedure. It has been determined that a lack of lubricant on the m12 thread could have led to malfunction/seize-up of the remobilization tool f/lotus+uss-ii-polya 03. 603. 108. For the damaged components it is possible to state that the pieces have not been assembled/handled post production in the correct way. Over all the root cause for this complaint could not be defined exactly. 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
Concomitant device: a 1x uss-ii polyaxial cancellous bone screw, (part 04. 607. 281s, lot unknown).
 
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Brand NameUSS-II NUT TAN GREEN
Type of DeviceAPPLIANCE,FIXATION,SPINAL
Manufacturer (Section D)
SYNTHES MEZZOVICO
zona industriale 4
mezzovico CH680 5
SZ CH6805
Manufacturer (Section G)
SYNTHES MEZZOVICO
zona industriale 4
mezzovico CH680 5
SZ CH6805
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6347886
MDR Text Key67924762
Report Number1000562954-2017-10015
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07611819728011
UDI-Public(01)07611819728011(10)L116830
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082572
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
Report Date 01/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number499.294
Device Lot NumberL116830
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2016
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: 02/21/2017 Patient Sequence Number: 1
Treatment
1X UNK SCREW.
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