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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NAIL EXTRACTOR ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC NAIL EXTRACTOR ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.037.032
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: investigation flow: damage. Visual inspection: the nail extractor (part # 03. 037. 032/ lot # 9251399) was received at us customer quality (cq). Upon visual inspection, the distal tip was found to be deformed, confirming the complaint condition. No other issues were identified with the returned device. The damaged tip of the device is an end of life indicator for the device. Investigation conclusion: this complaint was confirmed, as the distal tip was deformed. After a visual inspection per guidance provided in windchill document # (b)(4), it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required. During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities. Device history lot: part: 03. 037. 032, lot: 9251399, manufacturing site: hägendorf, release to warehouse date: nov 18, 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.
 
Event Description
It was reported that a proximal femoral nailing system (tfna) nail extractor was found damaged in the sterile processing department (spd). There was no patient involvement. This report is for one (1) nail extractor. This is report 1 of 1 for (b)(4).
 
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Brand NameNAIL EXTRACTOR
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10511895
MDR Text Key208148232
Report Number2939274-2020-04066
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.032
Device Catalogue Number03.037.032
Device Lot Number9251399
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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