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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM; PLATE, BONE
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SYNTHES GMBH 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM; PLATE, BONE Back to Search Results
Catalog Number 04.503.606.01S
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Occupation: initial reporter is a synthes sales representative.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 synthes (b)(6) reports an event as follows: on (b)(6) 2020, a removal procedure was performed to remove the screws.During the screw removal, a thin string-like silver foreign object was found.They tried to figure out where the foreign object came from but were not able to identify it.The original procedure occurred on (b)(6) 2016.This report is for a matrixmandible locking screw.This is report 6 of 10 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: product was not returned and therefore, no further investigation is possible.This complaint will be rated as confirmed as the investigation has shown that the observed damage is consistent with the reported complaint condition.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.
 
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Brand Name
2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM
Type of Device
PLATE, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10950187
MDR Text Key225816976
Report Number8030965-2020-09406
Device Sequence Number1
Product Code JEY
UDI-Device Identifier07611819939714
UDI-Public(01)07611819939714
Combination Product (y/n)N
PMA/PMN Number
K063790
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.503.606.01S
Was Device Available for Evaluation? No
Date Returned to Manufacturer12/01/2020
Date Manufacturer Received12/09/2020
Patient Sequence Number1
Treatment
LOCK SCR Ø2 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2 SELF-TAP L14 TAN 1U I/CLIP; LOCK SCR Ø2 SELF-TAP L16 TAN 1U I/CLIP; MATMAND PL STRAIG 6HO T1.5 TI; MATMAND SCR Ø2 SELF-TAP L5 TAN 1U I/CLIP; MATMAND SCR Ø2.4 SELF-TAP L6 TAN 1U I/CL; MATRIXMAND MINI-TENSIONPL NARROW CENTRE
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