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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 292.620
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2019
Event Type  malfunction  
Manufacturer Narrative
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: during an unknown procedure on (b)(6) 2019 a guide wire with threaded wire became bent and broke.No fragments remained in the patient.Surgical delay and patient status is unknown.Concomitant device reported: unknown powered drivers/ handpieces (part #: unknown, lot #: unknown, quantity #: 1).Unknown 3.5 cannulated screw (part #: unknown, lot #: unknown, quantity #: 1).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.H3, h6: part: 292.620, lot: l831613, manufacturing site: balsthal, release to warehouse date: april 24, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the guidewire ø1.25 w/thread-tip w/trocar l1 was received at us customer quality (cq).The distal tip of the device is both bent and broken.The tip is broken such that none of the threaded tip remained.There are clear shear marks on the cross section of where the distal tip broke off.The received condition is consistent with the complaint condition thus the complaint is confirmed.Dimensional inspection: dimensional analysis could not be performed on the distal tip due to the nature of the damage.Dimensional inspection was performed on the shaft proximal to the damage.Shaft diameter = conforming manufacturing record evaluation: the received guidewire ø1.25 w/thread-tip w/trocar l1 was manufactured at the balsthal site on april 24, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint was confirmed for the received guidewire ø1.25 w/thread-tip w/trocar l1 as the distal of tip of the device was both bent and broken.The distal tip of the device broke such that none of the threaded tip remained.There were clear shear marks on the remaining cross-section face where the device broke.Although no definitive root-cause can be determined, it is possible that the device experienced unintended forces during use.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 preventative 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.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 Key8896462
MDR Text Key154410967
Report Number8030965-2019-67255
Device Sequence Number1
Product Code LRN
UDI-Device Identifier07611819013841
UDI-Public(01)07611819013841
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
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 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number292.620
Device Lot NumberL831613
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2019
Date Manufacturer Received09/30/2019
Patient Sequence Number1
Treatment
UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - SCREWS: 3.5 MM CANNULATED; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - SCREWS: 3.5 MM CANNULATED
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