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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MEZZOVICO END-CAP F/A2FN CANN EXTENS. 5 TAN GREY ROD, FIXATION, INTRAMEDULLARY

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SYNTHES MEZZOVICO END-CAP F/A2FN CANN EXTENS. 5 TAN GREY ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.009.001S
Device Problem Difficult to Remove (1528)
Patient Problems Sedation (2368); No Code Available (3191)
Event Date 11/01/2016
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Additional narrative: additional device product code is hwc. (b)(4). Implant date: unknown. (b)(6). For additional medical intervention due to reported event. The 510(k): device is not distributed in the united states, but is similar to device marketed in the usa. The subject device has been received and is currently in the evaluation process. A device history record review was performed for the subject device lot number 9804670. Manufacturing location: synthes (b)(4). Date of manufacture: feb 13, 2015. Expiration date: feb 1, 2025. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. 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 during extraction surgery of an expert nail, the surgeon couldn't remove the end cap using a screw driver. The surgeon had to use a bone chisel to push out and then pull out the nail with the end cap. Extended anesthesia was needed. There was a surgical prolongation of 90 minutes reported. There is no information available about patient and surgical outcome. The hardware was initially implanted on an unknown date to treat a right femoral diaphyseal fracture. This report is 1 of 2 for (b)(4).
 
Manufacturer Narrative
A product development investigation was performed for the subject device (end-cap f/a2fn cann extens. 5 tan grey, part number 04. 009. 001s, lot number 9347819). The subject device was returned with the complaint condition stating the upon visual inspection of the complaint implants it can be seen that the parts are blocked in each other as reported, this thus confirming the complaint description. End-cap (04. 009. 001s / 9347819): a device history record (dhr) review was performed for the affected lot, (b)(4) parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure. The article was manufactured in february 2015. No non-conformance reports (ncrs) were marked in the dhr during production. Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number. Nail (04. 009. 448s / 7682325): a device history record (dhr) review was performed for the affected lot, (b)(4) parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure. The article was manufactured in december 2011. No ncrs were marked in the dhr during production. Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number. Further investigation on the parts has shown that the end-cap is badly damaged around the screw head, as well in the recess. The nail is visible in used condition; the nail is damaged on the proximal end due to the removal attempt. Because of the damage and that the parts are blocked in each other, the complaint relevant dimensions cannot be checked for dimensional accuracy and the exact reason for this occurrence was not able to determined. 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.
 
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Brand NameEND-CAP F/A2FN CANN EXTENS. 5 TAN GREY
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 Key6127739
MDR Text Key60902704
Report Number1000562954-2016-10216
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
Report Date 11/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.009.001S
Device Lot Number9347819
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2015
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: 11/25/2016 Patient Sequence Number: 1
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