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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
Model Number 03.037.024
Device Problem Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 04/08/2018
Event Type  Injury  
Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.(b)(4).The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 reported that during a procedure on (b)(6) 2018 a spiral blade inserter did not fit properly through the blade insertion sleeve.It's jammed inside the sleeve.The procedure was completed successfully by using a lag screw instead of a blade.There was a surgical delay of ten minutes to complete the procedure.This report is for one (1) helical blade inserter.This is report 1 of 2 for complaint (b)(4).
 
Manufacturer Narrative
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
During manufacturer¿s preliminary analysis of the returned device it was observed that the yellow etching on the helical blade inserter is missing.
 
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.Part 03.037.024, lot t144458: release to warehouse date: january 20, 2017.Manufacture site: tuttlingen.A review of the device history records (dhr) 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.No non-conformance reports (ncrs) were generated during the production of this device.A product investigation was completed: the returned helical blade inserter (part 03.037.024, lot t144458) is included in the trochanteric fixation nail advanced system and is used to help with head element insertion.The returned inserter was received with minor superficial marks, a missing color indicator, and spiraling scratches resembling the rifling pathways of blade guide sleeves.Relevant actions have already been initiated to address the peeling off of the color indicators.When it was attempted to insert the returned inserter into the returned sleeve, the gouging and inner deformations of the sleeve was found to contribute to the inserter not being able to be inserted into the sleeve, which confirmed the complaint condition.The relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.No material review reports (mrrs), non-conformance reports (ncrs), or actions related to the complaint condition were generated during production of the returned part(s).Review of device history record(s) showed that there were no issues during the manufacture of the product(s), which would contribute to the complaint condition.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.The dimensional check found the device to be conforming.Based on the available information it is not possible to determine a definitive root cause for the complaint condition.The returned inserter and sleeve were received with missing color indicators, which are intended to help ensure proper insertion, which could have contributed to the inserter not being inserted as intended.The damage to the inner cannulation and the rifling pathways within the sleeve indicate that improper technique was coupled with excessive force, which contributed to the noticed damage and subsequently the complaint condition.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 Key7472065
MDR Text Key106855905
Report Number2939274-2018-51949
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982070401
UDI-Public(01)10886982070401
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,health
Type of Report Initial,Followup,Followup
Report Date 04/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03.037.024
Device Catalogue Number03.037.024
Device Lot NumberT144458
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Date Manufacturer Received06/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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