• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH K-WIRE Ø0.8 L150 SST 10U; WIRE, SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES GMBH K-WIRE Ø0.8 L150 SST 10U; WIRE, SURGICAL Back to Search Results
Catalog Number 292.090.10
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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.Device is not distributed in the united states, but is similar to device marketed in the usa.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
 
Event Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the k-wire in question had been bent already when it arrived at the hospital.This k- wire was not used in surgery.This k- wire was delivered as a replacement for the previous defective product captured in (b)(4).This report is for one (1) k-wire ø0.8 l150 sst 10u.This is report 5 of 10 for complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
K-WIRE Ø0.8 L150 SST 10U
Type of Device
WIRE, SURGICAL
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK BALSTHAL (CH)
dornacherstrasse 20
balsthal 4710
SZ   4710
Manufacturer Contact
kate karberg
1302 wrights lane east
west chester, PA 19380
8472871282
MDR Report Key15675067
MDR Text Key306730906
Report Number8030965-2022-08954
Device Sequence Number1
Product Code LRN
UDI-Device Identifier07611819321366
UDI-Public(01)07611819321366
Combination Product (y/n)N
Reporter Country CodeJA
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 Number292.090.10
Device Lot Number803P222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2022
Initial Date FDA Received10/26/2022
Supplement Dates Manufacturer Received11/17/2022
Supplement Dates FDA Received11/18/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/27/2022
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
-
-