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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE 25 X 13 X 20 X 20 X 20 X 20 MM (4 LEGS) H SHAPED IMPLANT; STAPLE, FIXATION, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE 25 X 13 X 20 X 20 X 20 X 20 MM (4 LEGS) H SHAPED IMPLANT; STAPLE, FIXATION, BONE Back to Search Results
Model Number EL-252013H
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Patient information not available for reporting.Lot number is unknown.Date of implantation is unknown.Device has not been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter address and telephone not available for reporting.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
It was reported that on an unknown date, the surgeon used elite h implants for a midfoot fusion procedure.Postoperative x-rays showed two broken staples.One staple had one leg broken at top of the second barb in the talonavicular (tn) joint and the other staple had one broken leg at the shoulder in the calcaneocuboid (cc) joint.Patient had no complaints of pain or any symptoms.There was no revision procedure performed.This report is for an elite 25 x 13 x 20 x 20 x 20 x 20 mm (4 legs) h shaped implant.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.
 
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.Patient initials were identified.Device history record (dhr) review: part number: el-252013h; bme lot number: bel170830; manufacturing date or release to warehouse date: 27 nov 2017; place of manufacture: biomedical enterprises, san antonio, tx; lot expiration date: 2 nov 2022.No nonconformance manufacturing records (ncmrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Investigation summary: investigation was performed based on x-rays provided in the file (b)(4) image for case 1 (b)(6) 2018).The x-rays show two broken elite h staples.The first staple (el-202013h) was installed on the tn joint and broke at the 2nd barb of one of the legs, the second staple (el-252013h) was installed at the cc joint and broke on one of the shoulders.Devices were not returned to cq for device evaluation, therefore, material assessments or dimensional inspections could not be performed.The complaint condition of a broken device is confirmed but due to an unknown cause.Based on the investigation findings, it has been determined that no further 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
ELITE 25 X 13 X 20 X 20 X 20 X 20 MM (4 LEGS) H SHAPED IMPLANT
Type of Device
STAPLE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key7856624
MDR Text Key119657249
Report Number2939274-2018-53664
Device Sequence Number1
Product Code JDR
UDI-Device Identifier00810633021743
UDI-Public(01)00810633021743
Combination Product (y/n)N
PMA/PMN Number
K150125
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 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/02/2022
Device Model NumberEL-252013H
Device Catalogue NumberEL-252013H
Device Lot NumberBEL170830
Was Device Available for Evaluation? No
Date Manufacturer Received10/09/2018
Patient Sequence Number1
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