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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPINDLE NUT TRACTION, APPARATUS, NON-POWERED

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPINDLE NUT TRACTION, APPARATUS, NON-POWERED Back to Search Results
Model Number 394.42
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Additional narrative: reporter is a j&j representative. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
 
Event Description
It was reported that on an unknown date, the universal chuck, screwdriver shaft, hammer guide, stardrive screwdriver shaft, cannulated hexagonal screwdriver, threaded rod and universal chuck with t-handle are found broken during the inspection outside the surgery. Patient involvement is unknown. This complaint involves seven (7) devices. This report is for (1) spindle nut. This report is 8 of 8 for (b)(4).
 
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Brand NameSPINDLE NUT
Type of DeviceTRACTION, APPARATUS, NON-POWERED
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12392797
MDR Text Key268975600
Report Number2939274-2021-05055
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number394.42
Device Catalogue Number394.42
Device Lot Number38092
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/31/2021 Patient Sequence Number: 1
Treatment
CANNULATED 4.0MM HEXAGONAL SCREWDRIVER; HAMMER GUIDE FOR SLIDE HAMMER; SD SCRWDRVR SHFT/T4 50/SELF-RETAIN/HXC; SDDRIVE SCREWDRIVER SHAFT T8 105MM; THREAD-ROD Ø14 L330 F/LARGE-DISTRACT; UNIVERSAL CHUCK; UNIVERSAL CHUCK WITH T-HANDLE
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