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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH VET K-WIRE Ø1 W/DOUB TIP L150 SST 10U; WIRE, SURGICAL

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SYNTHES GMBH VET K-WIRE Ø1 W/DOUB TIP L150 SST 10U; WIRE, SURGICAL Back to Search Results
Catalog Number VW1004.15.10
Device Problems Material Deformation (2976); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2023
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 expected to be returned for manufacturer review/investigation, but has yet to be received.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 synthes reports an event in sweden as follows: it was reported that all items were delivered to the customer bent.Has not been used for surgery.It was discovered at delivery.There were no patient outcomes or consequences.This report is for one (1) vet k-wire ø1 w/doub tip l150 sst 10u.This is report 6 of 6 for complaint (b)(4).
 
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Brand Name
VET K-WIRE Ø1 W/DOUB TIP L150 SST 10U
Type of Device
WIRE, SURGICAL
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key18209684
MDR Text Key329261050
Report Number8030965-2023-14829
Device Sequence Number1
Product Code LRN
UDI-Device Identifier07611819502642
UDI-Public(01)07611819502642
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
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 NumberVW1004.15.10
Device Lot Number7520P74
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/02/2023
Initial Date FDA Received11/27/2023
Supplement Dates Manufacturer Received12/06/2023
Supplement Dates FDA Received12/28/2023
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 Unknown
Patient Sequence Number1
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