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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM F/IM NAILS-STERILE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES MEZZOVICO 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM F/IM NAILS-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.005.438S
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/24/2015
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Additional narrative: patient information was not provided by reporter. It is unknown when the instrument was broken and it was reportedly discovered to be broken on (b)(6) 2015. (b)(4). The subject device is expected to be returned to the synthes manufacturer for evaluation. (b)(6). A device history record review was performed for the subject device lot. 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Synthes (b)(4) reported events in (b)(6) as follows: it was reported that during a procedure to treat a tibial diaphysis fracture by implanting an expert tibial nail system, the surgeon found the locking screw was bent. It was reported that the surgeon was inserting the locking screw in the upper position of the proximal locking slot according to the technique guide to perform the compression procedure. After compression was achieved, the surgeon discovered that the locking screw was bent and had to remove it. The surgeon inserted an alternative screw into the static screw slot. The surgery was extended ten minutes due to the reported event. There was no patient harm. This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. A manufacturing investigation was performed for the subject device (4. 0mm ti locking screw w/t25 stardrive 48mm f/im nails-sterile, part number 04. 005. 438s, lot number 3700003). The returned screw was received bent as complained. The surface of the tip section and tip thread section were damaged. The screw recess shows traces of use. A functional test of the recess with screwdriver part number 03. 019. 020 could be executed successfully. There were no problems with insertion or removal of screwdriver found. The measured thread diameter of the unbent section below screw head showed conformity to specifications. As previously reported, the review of the manufacturing documents showed that there were no manufacturing deviations. Though the complaint condition was confirmed, it is not confirmed from a manufacturing standpoint. A definitive root cause could not be identified but it is likely that too much force was applied during the compression procedure which led to the observed damage and bending 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.
 
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Brand Name4.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM F/IM NAILS-STERILE
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
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5365006
MDR Text Key35921634
Report Number1000562954-2016-10008
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK103002
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 12/24/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2021
Device Catalogue Number04.005.438S
Device Lot Number3700003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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