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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER; ROD,FIXATION,INTRAMEDULLARY
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.024
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Synthes sales representative.A review of the device history records has been requested.Device was used for treatment, not diagnosis.
 
Event Description
Synthes europe reports an event in (b)(6) as follows: it was reported that during insertion of a trochanteric fixation nail advanced (tfna) nail on an unknown date, the helical blade inserter was not able to pass the threaded coupling screw.The surgeon have to switched from helical blade to lag screw since the coupling screw was able to pass with the insertion handle for the lag screw.It is unknown if there was a surgical delay.Patient status and surgical outcome were both unknown.Concomitant device reported: unknown coupling screw (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is 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 returned device was manufactured in september 2016.No design or manufacturing defect or deficiency was observed during the investigation.The reported complaint condition was not able to be confirmed or replicated.The overall complaint condition is confirmed because of the missing epoxy and malformed external features at the distal tip.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being dropped, struck off-axis or damaged during usage or handling or sterile processing).Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Further review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.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 lot part number: 03.037.024, synthes lot number: t138805, release to warehouse date: 26-sep-2016, manufacture site: tuttlingen, part expiration date: n/a.Further review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.Investigation summary visual inspection: visual inspection of the returned device performed at customer quality identified post manufacturing damage to the external diameter at the distal tip.The damage resembles witness marks from serrated teeth pliers.The returned device was also found to be missing sections of the alignment indicator epoxy.The missing epoxy was investigated and does not require any additional investigation in this complaint investigation.No damage to the inside diameter or other features that are relevant to the interface with a coupling screw were observed.Functional test: the functional test was not able to be performed and the complaint was not able to be replicated because the coupling screw was not returned.Dhr review: the returned device was manufactured in september 2016.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.Dimensional inspection: the inside diameter at the distal tip measured 6.18mm which is within specification of 6.2mm +/-0.04mm per tfna helical blade inserter shaft component design drawing investigation conclusion: the reported complaint condition was not able to be confirmed or replicated.The overall complaint condition is confirmed because of the missing epoxy and malformed external features at the distal tip.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being dropped, struck off-axis or damaged during usage or handling or sterile processing).The missing epoxy was investigated under and does not require any additional investigation in this complaint investigation.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.
 
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Brand Name
HELICAL BLADE INSERTER
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8062153
MDR Text Key126890946
Report Number2939274-2018-54942
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819642508
UDI-Public(01)07611819642508
Combination Product (y/n)N
PMA/PMN Number
K131548
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 10/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.037.024
Device Lot NumberT138805
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2018
Date Manufacturer Received05/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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