NAIL EXTRACTOR 03.037.032

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for NAIL EXTRACTOR 03.037.032 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[185546867] Investigation summary: investigation flow: damage. Visual inspection: the nail extractor (p/n # 03. 037. 032, l/n # 9343591) was received at us cq with the distal threads stripped. This is consistent with the reported complaint condition, thus confirming the complaint. Dimensional inspection: dimensional analysis was completed. Conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information. This complaint is confirmed however 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 because of this evaluation. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Device history lot. Part: 03. 037. 032. Lot: 9237381. Manufacturing site: (b)(6). Release to warehouse date: (b)(6), 2014. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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.
Patient Sequence No: 1, Text Type: N, H10


[185546868] It was reported that on an unknown date, during inspection at the sterile processing department (spd), a driving cap, radiolucent insertion handle, helical blade extractor and nail extractor were noted to have an unknown malfunction. The driving cap and the insertion handle where broke at the connection of the two and the helical blade extraction and the exaction nail were both stripped at the threads. There was no patient involvement. This complaint involves three devices. This is report 3 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01567
MDR Report Key9889187
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-02-18
Date Mfgr Received2020-03-24
Device Manufacturer Date2014-12-16
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1SYNTHES HAEGENDORF GMBH-CN
Manufacturer StreetIM BIFANG 6
Manufacturer CityHAEGENDORF 4614
Manufacturer CountrySZ
Manufacturer Postal Code4614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNAIL EXTRACTOR
Generic NameROD,FIXATION,INTRAMEDULLARY
Product CodeHSB
Date Received2020-03-27
Returned To Mfg2020-03-06
Model Number03.037.032
Catalog Number03.037.032
Lot Number9237381
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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