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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM THREADED GUIDE WIRE 230MM; WIRE, SURGICAL
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM THREADED GUIDE WIRE 230MM; WIRE, SURGICAL Back to Search Results
Catalog Number 292.650S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/21/2019
Event Type  Injury  
Manufacturer Narrative
Additional procode: jdw.Complainant part is not expected to be returned for manufacturer review/investigation.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 the (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2019, the tip of the guidewire broke off inside patient¿s bone/femoral nail.The surgeon decided to leave it there.Procedure outcome and patient status is unknown.This report is for a 2.0mm threaded guide wire 230mm.This is report 1 of 1 for pc-(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.A device history record (dhr) review was conducted: part: 292.650s, lot: l949008 , manufacturing site: selzach , supplier: (b)(4), release to warehouse date: 26.Aug.2018, expiry date: 01.Aug.2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part was manufactured in balsthal part: 292.650, lot: l922612, manufacturing site: balsthal, release to warehouse date: 05.Jun.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.The initial complaint was reviewed and found not reportable.It was determined this report was a duplicate of another reported complaint (b)(4); this event is captured on manufacturer report number 8030965-2019-70677.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
The initial complaint was reviewed and found not reportable.It was determined this report was a duplicate of another reported complaint (b)(4); this event is captured on manufacturer report number 8030965-2019-70677.
 
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Brand Name
2.0MM THREADED GUIDE WIRE 230MM
Type of Device
WIRE, SURGICAL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9513001
MDR Text Key189006569
Report Number8030965-2019-71389
Device Sequence Number1
Product Code LRN
UDI-Device Identifier07611819733152
UDI-Public(01)07611819733152
Combination Product (y/n)N
PMA/PMN Number
PREAMEND
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 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2018
Device Catalogue Number292.650S
Device Lot NumberL949008
Was Device Available for Evaluation? No
Date Manufacturer Received01/29/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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