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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP DHP 2.7/3.5 MED W/EXT LE SHORT 1- PLATE, FIXATION, BONE

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SYNTHES GMBH VA-LCP DHP 2.7/3.5 MED W/EXT LE SHORT 1- PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.117.701S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2022
Event Type  malfunction  
Manufacturer Narrative
Additional device product codes hwc. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, the patient underwent the open reduction internal fixation with the plate and the va locking screw for the distal fracture of the left humerus. When the surgeon used the plate and the va locking screw, they were not locked. The surgeon checked the image intensifier, it was confirmed that the screw deviated anteriorly from the bone. The surgeon tried to remove the screw; however, the locking mechanism of the plate was broken. It took time to remove; however, the surgeon was able to remove the screw and the internal fixation was completed. The surgery was completed successfully with approximately 20 minutes delay. No further information is available. This report is for one (1) va-lcp dhp 2. 7/3. 5 med w/ext le short 1. This is report 1 of 2 for complaint (b)(4).
 
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Brand NameVA-LCP DHP 2.7/3.5 MED W/EXT LE SHORT 1-
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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14428286
MDR Text Key291959533
Report Number8030965-2022-03253
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.117.701S
Device Lot Number367P165
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/18/2022 Patient Sequence Number: 1
Treatment
VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L24 TA
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