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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; APPLIANCE,FIXATION,NAIL
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC; APPLIANCE,FIXATION,NAIL Back to Search Results
Device Problem Compatibility Problem (2960)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Patient information not available for reporting.This report is for an unknown lag screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follows: it was reported during an unknown procedure on an unknown date, surgeon was connecting the dynamic hip screw/dynamic condylar screw (dhs/dcs) coupling screw to the lag screw prior to implanting the lag screw, when the coupling screw seemed to cross thread and the threaded tip broke off.Another dhs/dcs coupling screw and lag screw were retrieved from another dhs/dcs set to complete the procedure.It is not known if surgery was delayed.Patient outcome was not reported.This report is for one (1) unknown lag screw.This is report 2 of 2 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.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
It was further reported that there was no allegation against the lag screw as it was implanted in the patient with another available dhs coupling screw.
 
Event Description
The initial complaint was reviewed and found not reportable.The information in this complaint record reasonably suggests that there is no allegation of a complaint against this device and there is no reported malfunction or adverse event caused or contributed to with this device.The device functioned as intended.It was reported that there was no malfunction of the lag screw and it was implanted in the patient.Should further information become available this determination will be reviewed.
 
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 initial complaint was reviewed and found not reportable.The information in this complaint record reasonably suggests that there is no allegation of a complaint against this device and there is no reported malfunction or adverse event caused or contributed to with this device.The device functioned as intended.It was reported that there was no malfunction of the lag screw and it was implanted in the patient.Should further information become available this determination will be reviewed.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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Type of Device
APPLIANCE,FIXATION,NAIL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key7691515
MDR Text Key114417907
Report Number2939274-2018-52904
Device Sequence Number1
Product Code KTT
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 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received09/14/2018
Patient Sequence Number1
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