Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - GUIDE/COMPRESSION/K-WIRES; 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
 

OBERDORF SYNTHES PRODUKTIONS GMBH UNK - GUIDE/COMPRESSION/K-WIRES; WIRE, SURGICAL Back to Search Results
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown k-wire/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.(b)(4).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 (b)(6) reports an event as follows: it was reported during a triple arthrodesis foot procedure on (b)(6) 2019, a k-wire broke while inserting a 4.5mm cannulated screw.The fragment of the wire was embedded in the patient's bone and was not able to be removed.Additional x-rays were taken which confirmed the fragment was lodged in the patient's bone.The k-wire was changed and the procedure was completed successfully.Surgery was delayed 15 minutes.There are no plans to remove the wire fragments.Patient recovery will be monitored.It was further noted after post-surgery inspection of the surgical kit that the incorrect k-wires were present.The wires were too thin for use with the 4.5mm cannulated screws.The incorrect wires were removed and the kit was restocked with the correct corresponding k-wires.Concomitant devices: cannulated screw (part: unknown, lot: unknown, quantity: 1).This is report 2 of 2 for (b)(4).This report is for an unknown guide/compression k-wire.
 
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 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.
 
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: h3, h6 investigation summary: the complaint is confirmed as we are able to confirm the complaint description based on the received pictures.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNK - GUIDE/COMPRESSION/K-WIRES
Type of Device
WIRE, SURGICAL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9281109
MDR Text Key180427623
Report Number8030965-2019-69990
Device Sequence Number1
Product Code LRN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/20/2019
Patient Sequence Number1
Treatment
UNK - SCREWS: 4.5 MM CANNULATED.
Patient Outcome(s) Required Intervention;
-
-