MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAND PIECE FOR BATTERY POWERED DRIVER; SCREWDRIVER

Model Number 05.000.008

Device Problem Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

Part # 05.000.008, synthes lot # 006696, supplier lot # 006696, release to warehouse date: 06 jun 2017, supplier: (b)(4), no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Service and repair evaluation: it was reported that on (b)(6) 2021, the hand piece for battery powered driver med speed does not work.The repair technician reported the bearings are grinding and there is debris covering the column.The device did not run in forward.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.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 med speed did not work.The issue was observed during routine inspection.There was no patient involvement.This report is for 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: SCREWDRIVER
• 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 Key: 11855564
• MDR Text Key: 251787378
• Report Number: 2939274-2021-02457
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10887587024585
• UDI-Public: 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2021

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: 006696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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