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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TI LCP® ONE-THIRD TUBULAR PLATE W/COLLAR 5 HOLES/57MM; PLATE, FIXATION, BONE

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SYNTHES GMBH TI LCP® ONE-THIRD TUBULAR PLATE W/COLLAR 5 HOLES/57MM; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 441.351S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2023
Event Type  malfunction  
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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 japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent a orif for distal medial tibia & distal anterolateral tibia.Adt plate was used on distal anterolateral tibia, and 1/3 circle plate was used on distal medial tibia.During the surgery, a drill-guide/3.5mm with a screw (03.133.004) was not attached to the plate.Therefore, instead of locking screw, cortex one was inserted in the plate.The surgery was completed successfully within 30 minutes surgical delay.No further information is available.This report is for a ti lcp® one-third tubular plate w/collar 5 holes/57mm.This is report 5 of 5 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.H4,h6 a manufacturing record evaluation was performed for the finished device product code: 441.351s-15, lot no: 6140p82, it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 09-jun-2023, manufacturing site:jabil grenchen, expiry date:01-jun-2033.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
TI LCP® ONE-THIRD TUBULAR PLATE W/COLLAR 5 HOLES/57MM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
JABIL GRENCHEN
solothurnstrasse 186
grenchen CO 2540
SZ   2540
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key18518853
MDR Text Key332935884
Report Number8030965-2024-00899
Device Sequence Number1
Product Code HRS
UDI-Device Identifier10886982221780
UDI-Public(01)10886982221780
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K011335
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number441.351S
Device Lot Number6140P82
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/25/2023
Initial Date FDA Received01/16/2024
Supplement Dates Manufacturer Received01/22/2024
Supplement Dates FDA Received02/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
THREADED DRILL GUIDE 2.8 F/SCREW 3.5 F/V; THREADED DRILL GUIDE 2.8 F/SCREW 3.5 F/V; THREADED DRILL GUIDE 2.8 F/SCREW 3.5 F/V; THREADED DRILL GUIDE 2.8 F/SCREW 3.5 F/V
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