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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 292.62
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Failure of Implant (1924); Injury (2348); Foreign Body In Patient (2687)
Event Date 05/27/2020
Event Type  Injury  
Manufacturer Narrative
Additional procode: hty.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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 on (b)(6) 2020 during an unknown procedure, the 1.25mm threaded guide wire 150mm broke.There is no additional information available.This complaint involves one (1) device.This report is for one (1) 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.H10 additional narrative: h3, h6: part: 292.620, lot: 19p9665, manufacturing site: balsthal, release to warehouse date: october 11, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the guidewire ø1.25 w/thread-tip w/trocar l1 was received at us customer quality (cq).Upon visual inspection, the threaded distal tip was broken off.The broken piece was not returned.Dimensional inspection: measured dimensions: shaft od = conforming.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the visual inspection of the returned device showed that the threaded tip has broken off.However, the investigation can't confirm the reported condition of "foreign body left in patient" as there no evidence such as x-ray images provided illustrating this defect.Although no definitive root cause could be determined based on the provided information, it is likely that the device encountered excessive forces higher than what the device was validated to withhold.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.H10 additional narrative: h3, h6: the device was 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.
 
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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 Key10203616
MDR Text Key197316956
Report Number8030965-2020-04511
Device Sequence Number1
Product Code LRN
UDI-Device Identifier07611819013841
UDI-Public(01)07611819013841
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 06/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number292.62
Device Lot Number19P9665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Date Manufacturer Received04/16/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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