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

Model Number 05.000.008

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: gxl; hxx.Reporter is a j&j sales representative.A product investigation was conducted.Service and repair evaluation: it was reported that on an unknown date, the hand piece for battery powered driver is in need of repair.The repair technician reported the device makes an atypical sound, motor had debris on it and bearings were grinding.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 on (b)(6) 2021 and will be returned to the customer upon completion of the service and repair process.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.Service and repair history: the previous service event for part number 05.000.008 with lot number(s) 6572 has been reviewed.The customer called in a service request for this item on (b)(6) 2021 for in need of repair.The item was previously returned for service on (b)(6) 2019 due to damaged component.The previous service condition of damaged component is not relevant to the current complained issue of in need of repair.The manufacture date of this item is 21-feb-2017.The service history review is unconfirmed.A shr was performed on the serviceable device and it was found that the device was manufactured on 21-feb-2017.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(4) no manufacturing record evaluation is required.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 hand piece for battery powered driver is in need of repair.The issue was observed during equipment check after being washed.There was no patient involvement.During manufacturer's investigation of the returned device it was identified that the device makes an atypical sound, motor had debris on it and bearings were grinding.This device condition was re-evaluated and determined to be reportable on (b)(6) 2021.This complaint involves one (1) hand piece for battery powered driver.This is report 1 of 1 for (b)(4).

• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11590471
• MDR Text Key: 247491194
• Report Number: 2939274-2021-01600
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10887587024585
• UDI-Public: (01)10887587024585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2021

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 Number: 05.000.008
• Device Catalogue Number: 05.000.008
• Device Lot Number: 006572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1