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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 No Consequences Or Impact To Patient (2199)
Event Date 05/24/2019
Event Type  malfunction  
Manufacturer Narrative
Additional device product code: 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 synthes reports an event in (b)(6) as follows: it was reported that during an unknown surgery on (b)(6) 2019, a guide wire ruptured during insertion of a screw.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity# unknown).This report is for one (1) 1.25mm threaded guide wire 150mm.This is report 1 of 1 for complaint (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.H3, h4, h6: a review of the device history record for sterilization only: part:292.620s , lot:4l16743, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 05.April 2019, expiry date: 01.April 2029.Non sterile part: part:292.620, lot: 4l02111, manufacturing site: balsthal, release to warehouse date: 25.March 2019.H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.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.
 
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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 Key8736901
MDR Text Key149269298
Report Number8030965-2019-65778
Device Sequence Number1
Product Code LRN
UDI-Device Identifier07611819733121
UDI-Public(01)07611819733121
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 05/30/2019
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 Number292.620S
Device Lot Number4L16743
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/30/2019
Initial Date FDA Received06/26/2019
Supplement Dates Manufacturer Received07/01/2019
Supplement Dates FDA Received07/23/2019
Patient Sequence Number1
Treatment
UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
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