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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.7/3.5MM TI VA-LCP MEDL DSTL HUM PL/1H/LT/69MM-SHORT-STER PLATE,FIXATION,BONE

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SYNTHES GMBH 2.7/3.5MM TI VA-LCP MEDL DSTL HUM PL/1H/LT/69MM-SHORT-STER PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.117.501S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2021
Event Type  malfunction  
Manufacturer Narrative
Additional procode: hwc. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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) 2021, the patient underwent the surgery for transcondylar humeral fracture. In the surgery, the plate in question was used. The third hole from the distal end of the plate was drilled with the variable angle drill guide and then the locking screw in question was inserted. The locking screw idled in the hole of the plate and did not lock. In the end, the surgeon was unable to insert the locking screw to the third hole and the surgery was completed successfully. The patient outcome was stable. No further information is available. Concomitant device reported: variable angle drill guide (part # 03. 133. 007, lot # unknown, quantity 1). This report is for one (1) 2. 7/3. 5mm ti va-lcp medl dstl hum pl/1h/lt/69mm-short-ster. This is report 2 of 2 for (b)(4).
 
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Brand Name2.7/3.5MM TI VA-LCP MEDL DSTL HUM PL/1H/LT/69MM-SHORT-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 Key11992884
MDR Text Key255993371
Report Number8030965-2021-04908
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.117.501S
Device Lot Number91P1865
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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