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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

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SYNTHES GMBH 3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT Back to Search Results
Catalog Number 441.901
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is an unknown date in 2021. 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. Code (b)(4) used to capture ¿injury. ¿ 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 patient underwent revision surgery on an unknown date due to broken philos plate. The osteosynthesis material was removed, curettage of the fracture focus and scarification until vitalized surfaces are left, the reduction is made by impacting the head to the diaphysis to improve contact and stabilizing with a new 5-hole philos plate, 9 locking screws 3. 5mm (1x28mm, 1x30mm, 2x40, 2x45, 3x55) and 2 cortical screws of 3. 5 x 30mm; 3 k-wires (1. 6mm and 2 of 2. 0mm) were used for temporary reduction of the fracture. Procedure was completed successfully. Patient outcome was okay. Patient originally underwent osteosynthesis of the left proximal humerus with a philos plate and of the left diaphyseal femur with an endomedullary nail on (b)(6) 2021. Patient returned on (b)(6) 2021 after falling from their own height following a slip while using crutches. Patient displayed fracture of the proximal humerus with a broken philos plate. The left femur did not show signs of fracture or joint alterations; consolidation was going well. This report is for a 3. 5mm titanium (ti) locking compression plate (lcp) proximal humerus plate. This is report 1 of 1 for (b)(4).
 
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Brand Name3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM
Type of DeviceAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK RARON (CH)
kanalstrasse west 30
raron 3942
SZ 3942
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12046658
MDR Text Key267469085
Report Number8030965-2021-05196
Device Sequence Number1
Product Code KTW
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K011815
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 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number441.901
Device Lot Number30P7521
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/13/2019
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: 06/22/2021 Patient Sequence Number: 1
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