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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PLATE CUTTER FOR MIDFACE PLATES INSTRUMENT, CUTTING, ORTHOPEDIC

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SYNTHES GMBH PLATE CUTTER FOR MIDFACE PLATES INSTRUMENT, CUTTING, ORTHOPEDIC Back to Search Results
Catalog Number 03.503.039
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: 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.
 
Event Description
It was reported that on (b)(6) 2021, during an unknown procedure, when using the pliers to cut the plate, a piece was broken and could not be closed. No patient consequence reported. This report is for one (1) plate cutter for midface plates this is report 1 of 1 for (b)(4).
 
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Brand NamePLATE CUTTER FOR MIDFACE PLATES
Type of DeviceINSTRUMENT, CUTTING, ORTHOPEDIC
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK SYNTHES UMKIRCH (DE)
im kirchenhürstle 4-6
umkirch bei freiburg 79224
GM 79224
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13191500
MDR Text Key286936499
Report Number8030965-2022-00170
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.503.039
Device Lot Number1976572
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/07/2022 Patient Sequence Number: 1
Treatment
UNK - PLATES: MATRIXMIDFACE
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