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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE, SURGICAL
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OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE, SURGICAL Back to Search Results
Catalog Number 292.620S
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/28/2018
Event Type  Injury  
Manufacturer Narrative
Additional procode: hty.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 an open reduction and internal fixation (orif) of the left ankle on (b)(6) 2018, when the guide wire was inserted into an unknown cannulated 3.5mm screw, the tip of the guide wire broke off and was retained in the patient's body.The surgeon was aware of the retained fragments of the device left in the patient, however, there was no required medical intervention performed.The surgery was completed successfully with no surgical delay.Patient outcome is unknown.Concomitant devices: 3.5mm cannulated screw (part: unknown, lot: unknown, quantity: 1).This report is for a 1.25mm threaded guide wire 150mm.This is report 1 of 1 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.The manufacturing documents were reviewed and no complaint related issues were found.The unsterile lot with a lot was manufactured in september 2018, all devices are distributed and we are not aware of any other complaint for this article- and lot combination, neither for sterile lot 1l74339 nor unsterile lot 1l57869.Product was not returned, therefore no further investigation is possible.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 history lot, part: 292.620s, lot: 1l74339, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 04.Oct.2018, expiry date: 01.Sep.2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The device was initially manufactured unsterile under part 292.620 with lot 1l57869.For this device a manufacturing record evaluation was performed and no non-conformances were identified.The raw material was confirmed to be correct per the specification with no non-conformance noted.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.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
1.25MM THREADED GUIDE WIRE 150MM
Type of Device
WIRE, SURGICAL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8378185
MDR Text Key137412037
Report Number8030965-2019-61554
Device Sequence Number1
Product Code LRN
UDI-Device Identifier07611819733121
UDI-Public(01)07611819733121
Combination Product (y/n)N
PMA/PMN Number
PRE-AMEND
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 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number292.620S
Device Lot Number1L74339
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/04/2019
Initial Date FDA Received02/28/2019
Supplement Dates Manufacturer Received04/01/2019
06/09/2021
Supplement Dates FDA Received04/11/2019
06/16/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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