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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/4H SHAFT/RT-STER PLATE, FIXATION, BONE

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SYNTHES GMBH 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/4H SHAFT/RT-STER PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.111.640S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2020
Event Type  malfunction  
Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent surgery for a right distal radius fracture. During the surgery, the surgeon tried to connect the guiding block to the plate, but they couldn¿t be connected completely and there was a gap between the plate and guiding block. They were disconnected once and he turned the screw of the guiding block, but had difficulty in turning the screw. The surgeon tried to connect them again and when he used an unknown screwdriver to connect them, the screw of the guiding block was broken and the fragment remained in the plate. The plate could no longer be used, another plate was used and the surgery was completed successfully with a twenty (20) minute delay. There was no effect to the patient. Concomitant device: unknown screwdriver (part# 03. 111. 600, lot# unknown, quantity 1). This report is for one (1) 2. 4mm ti va-lcp 2-clmn vlr dst rad pl 6h hd/4h shaft/rt-ster. This is report 1 of 2 for (b)(4).
 
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Brand Name2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/4H SHAFT/RT-STER
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10862270
MDR Text Key217136260
Report Number8030965-2020-09031
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K083694
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 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.111.640S
Device Lot Number63P9796
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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