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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM GUIDE WIRE 280MM WITH TROCAR TIP; WIRE, SURGICAL
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OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM GUIDE WIRE 280MM WITH TROCAR TIP; WIRE, SURGICAL Back to Search Results
Catalog Number 292.130.01
Device Problem Break (1069)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 06/15/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information is unknown.Lot number is unknown.Device has not been explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unknown.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(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 synthes europe reports an event in (b)(6) as follows: it was reported that during the fixation of a dens fracture on (b)(6) 2018, the surgeon was advancing the k-wire into the patients fractures and the k-wire broke.The doctor removed the held part of the wire and continued with another k-wire.The other fragment was impossible to retrieve and remains in the patient.The doctor said that he had to put pressure on the k-wire as the patient¿s bone was quite hard.He also mentioned that he had never seen a k-wire fracture in his experience.Surgery was completed successfully with a delay of 5 minutes.It was later discovered that the dens screw failed and patient was revised to posterior fusion of c1/c2 vertebrae.This related complaint is captured under (b)(4).This report is for a 1.25mm guide wire 280mm with trocar tip.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.Investigation site: (b)(4); selected flow: 5 broken.Visual inspection: upon visual inspection, it was noted that the tip of the k-wire is broken off.The broken off fragment was not returned for evaluation.In addition, the device is badly deformed/bent.Dimensional inspection: the relevant dimensions cannot be verified due to the damage incurred.Drawing/specification review: could not be performed due to missing lot number material review: the certificate of the raw material could not be reviewed due to missing lot information.Summary: the received condition of the k-wire is concordant with the complaint description and the complaint condition is confirmed.Since the exact lot number is not known, the present complaint cannot be further analyzed.We assume that the tip was probably broken due to incorrect handling.A definitive root cause was unable to be determined with the provided information.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 GUIDE WIRE 280MM WITH TROCAR TIP
Type of Device
WIRE, SURGICAL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7677691
MDR Text Key113748435
Report Number8030965-2018-54933
Device Sequence Number1
Product Code LRN
UDI-Device Identifier07611819319677
UDI-Public(01)07611819319677
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 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number292.130.01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2018
Date Manufacturer Received08/30/2018
Patient Sequence Number1
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