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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG ANGD BLADE PL 4 HOLES/60/60-SILE APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG ANGD BLADE PL 4 HOLES/60/60-SILE APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT Back to Search Results
Model Number 283.42S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or 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. Device history review - this lot met all visual and packaging and sterility criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.
 
Event Description
It was reported that on (b)(6) 2021, patient underwent a hardware removal procedure due to bone healing. The doctor scheduled a removal of an angled blade plae and the patient had a proximal femur correction on a previous date. Patient was healed and no longer needed the implanted hardware. Removal was very uneventful and had no patient consequence. This report is for one (1) 130 deg angled blade plate 4 holes/60mm/60mm-sterile. This is report 1 of 5 for complaint (b)(4).
 
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Brand Name130 DEG ANGD BLADE PL 4 HOLES/60/60-SILE
Type of DeviceAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11835200
MDR Text Key262154610
Report Number2939274-2021-02383
Device Sequence Number1
Product Code KTW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K914546
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2021
Device Model Number283.42S
Device Catalogue Number283.42S
Device Lot Number6976000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/17/2021 Patient Sequence Number: 1
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