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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAND PIECE FOR BATTERY POWERED DRIVER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAND PIECE FOR BATTERY POWERED DRIVER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 05.000.008
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional device product codes: gxl and hxx.Reporter is a synthes employee.A dhr was performed on the serviceable device and it was found that the device was manufactured on july 11, 2018.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.Service and repair evaluation: the customer reported that the hand piece for battery powered driver reverse speed does not work consistently.The repair technician reported the device did not run in fast forward, forward, or reverse, wires damaged, bearings grinding and debris in housing.Damaged component is the reason for repair.The cause of the issue is damaged component.The following parts were replaced: circuit board, motor, membrane switch/flex circuit, and all applicable components.The item was repaired per the inspection sheet, passed synthes final inspection and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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 (b)(6) 2021, the hand piece for battery powered driver reverse speed does not work consistently.The issue was observed during weekly audit.There was no patient involvement.This report involves one (1) hand piece for battery powered driver.This is report 1 of 1 for (b)(4).
 
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Brand Name
HAND PIECE FOR BATTERY POWERED DRIVER
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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 Key12172991
MDR Text Key261733884
Report Number2939274-2021-04106
Device Sequence Number1
Product Code HWE
UDI-Device Identifier10887587024585
UDI-Public10887587024585
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
Reporter Occupation Other
Type of Report Initial
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number05.000.008
Device Catalogue Number05.000.008
Device Lot Number007316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2021
Initial Date Manufacturer Received 06/24/2021
Initial Date FDA Received07/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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