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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 14MM; SCREW, FIXATION, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 14MM; SCREW, FIXATION, BONE Back to Search Results
Model Number 204.814
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
No patient involvement.Additional product codes: hrs, jds.Device was received damaged and was not implanted / explanted.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, 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 two deliveries were received containing empty device product packages on (b)(6) 2018.The first package from ups noted a missing locking compression plate (lcp) plate, the package was sealed on one end but unsealed on the other end.A device insert was enclosed in the package.Reportedly, indentations of a plate appeared on the package.The second package noted a missing two (2) cortex screws and a device inserts from each product.The box was sealed on both ends.Both ups shipper box was received intact.There is no patient involvement.This report is for one (1) 3.5mm cortex 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part 204.814, lot h607297: manufacturing location: (b)(4).Manufacturing date: april 02, 2018.Work order traveler met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and all components issued for packaging met current defined requirements.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.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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
3.5MM CORTEX SCREW SELF-TAPPING 14MM
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key7806771
MDR Text Key118094766
Report Number2939274-2018-53434
Device Sequence Number1
Product Code HWC
UDI-Device Identifier10886982146250
UDI-Public(01)10886982146250
Combination Product (y/n)N
PMA/PMN Number
K131186
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 08/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number204.814
Device Catalogue Number204.814
Device Lot NumberH607297
Was Device Available for Evaluation? No
Date Returned to Manufacturer09/12/2018
Date Manufacturer Received10/04/2018
Patient Sequence Number1
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