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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); Entrapment of Device (1212)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 09/06/2019
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter occupation: synthes employee.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: this was reported by rep on september 6, 2019 that during trimaleolar osteosynthesis surgery at pablo tobon uribe hospital with 4.0 cannulation system.When placing one of the cannulated screws 1.25mm, reference 292.620, one of them fractures at the tip when it hits the lateral cortex, and the fragment was not recovered.The surgery is finished without inconvenience and without consequences to the patient.The screw is marked on the equipment to be returned to the warehouse.Concomitant device reported: unknown cannulated screw (part #: unknown, lot #: unknown, quantity #: unknown).This is report 1 for 1 (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: b1: product problem info update.D10: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.G1: manufacturer information updated.H3, h6: investigation summary.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
 
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: additional patient and device codes.Part: 292.620, lot: 4l02096, manufacturing site: balsthal, release to warehouse date: 25.Mar.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection the returned guidewire was received broken at the distal tip.None of the device's threaded feature was present on the returned portion of the device; the broken fragment was not returned.The fracture was across the device's axis, where the fracture surface was slightly angular, which is typical of failure occurring during torsion, as well as being slightly cone-shaped, which is typical of failure occurring during tension.No abnormal material properties were noted on the fracture surface.Surface scratches were noted to the area of the device's etching, which obscured legibility of the etch.The scratches were uniform and spiral, indicating the device came in contact with another hard surface during use.Dimensional inspection drawing.Specified dimensions: shaft outer diameter = 1.25mm +0/-0.07, measured dimensions: shaft diameter = 1.245mm.Result: conforming.Measurement device: micrometer.Document/specification review drawing reviewed: (current & manufactured revision) no design issues were identified during investigation.Conclusion the complaint was confirmed with investigation.No manufacturing issues were identified during investigation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.As the event conditions were unknown, a root cause could not be determined; however, due to the nature of the fracture surface, it was possible that the device experienced unexpected abnormal forces during use.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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.
 
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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 Key9142101
MDR Text Key166984966
Report Number8030965-2019-68901
Device Sequence Number1
Product Code LRN
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 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number292.620
Device Lot Number4L02096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Initial Date Manufacturer Received 09/06/2019
Initial Date FDA Received10/01/2019
Supplement Dates Manufacturer Received10/14/2019
11/05/2019
Supplement Dates FDA Received10/31/2019
11/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK - SCREWS: CANNULATED
Patient Outcome(s) Required Intervention;
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