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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.5MM DHS/DCS GUIDE WIRE W/THREADED TIP 230MM; PIN,FIXATION,SMOOTH
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.5MM DHS/DCS GUIDE WIRE W/THREADED TIP 230MM; PIN,FIXATION,SMOOTH Back to Search Results
Catalog Number 338.000
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 12/04/2018
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.(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 an unknown surgical procedure on (b)(6) 2018, the dynamic hip screw/dynamic condylar screw (dhs/dcs) guide wire broke in the patient¿s femoral neck.Surgeon was not able to implant the intended dhs screw/blade and had to change the surgical plan to implantation of an intermediate hip prosthesis.The broken guide wire was removed from the femoral neck.Surgery was delayed an unspecified amount of time but was completed.Concomitant device: dhs/dcs screw/blade (part unknown, lot unknown, quantity 1).This report is for one (1) dhs/dcs guide wire.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 device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.Lot number provided for reporting.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 history records review was completed for part: 338.000, lot: l563858.Manufacturing location: balsthal, release to warehouse date: oct 05, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to specification for implants for surgery.Product investigation was completed.The tip of the device is broken as complained.Approximal 6cm of the distal trocar tip is broken off; the broken off part was also returned for investigation.Dimensional inspection met specifications.The returned device was manufactured according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformity reported.The complaint condition is confirmed as the tip of the device is broken.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformity reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.We found that the longer broken part of the guide wire runs in a cone at the end.This is an indication that the guide wire was cut off by the reamer and let us suppose that the wire was either bent after the insertion or that too high lateral stress, possibly by high soft tissue pressure, was applied during reaming.Finally we conclude that the cause of failure is not due to any manufacturing non-conformance.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.Device is not distributed in the united states, but is similar to device marketed in the usa.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
2.5MM DHS/DCS GUIDE WIRE W/THREADED TIP 230MM
Type of Device
PIN,FIXATION,SMOOTH
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8156140
MDR Text Key130174532
Report Number8030965-2018-58954
Device Sequence Number1
Product Code HTY
UDI-Device Identifier07611819021907
UDI-Public(01)07611819021907
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,Followup
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number338.000
Device Lot NumberL563858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2019
Date Manufacturer Received05/02/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age87 YR
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