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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL; ROD,FIXATION,INTRAMEDULLARY
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.019.008
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/26/2018
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.
 
Event Description
It was reported that on (b)(6) 2018, during an insertion of a proximal humeral nail, the holes in the targeting aiming arm are too tight to fit the triple trocar cannulas/trocar assembly.The surgeon has to really struggle to insert them through the outrigger.The surgeon used mineral oil on the outrigger and cannulas.It is unknown if there was any surgical delay.Patient outcome unknown.This complaint is for (1) aim-arm lat f/ml phn.This complaint involves (3) devices.This report is 1 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
 
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: 03.019.008, lot: 8241549, manufacturing site: haegendorf, release to warehouse date: 02.Apr.2013.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation summary visual inspection: visual inspection of the returned device performed at customer quality identified no damage that would inhibit function.Functional test: a functional test was not able to be performed because only the aiming arm was returned, the triple trocar from the event was not returned.Dhr review: the returned device was manufactured in april 2013 and is over 5 years old.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Document/specification review: no product design issues or discrepancies were observed during this investigation.Dimensional inspection: the distal targeting holes on the right side measured ø12.0, ø12.0, & ø12.0mm which is within specification the distal targeting holes on the left side measured ø12.0, ø12.0, & ø12.0mm which is within specification the proximal targeting holes on the right side measured ø13.0 & ø13.0mm which is within specification the proximal targeting holes on the left side measured ø13.0 & ø13.0mm which is within specification conclusion: a definitive root cause for the reported condition of the holes in the targeting aiming arm being too tight to fit the triple trocar cannulas/trocar assembly could not be determined based on the provided information.The reported complaint condition was not able to be confirmed or replicated at cq, all targeting holes measured within specification at cq and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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
AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL
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 Key8075365
MDR Text Key128065418
Report Number2939274-2018-55000
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819425583
UDI-Public(01)07611819425583
Combination Product (y/n)N
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 10/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.019.008
Device Lot Number8241549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2018
Date Manufacturer Received12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age55 YR
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