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

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

Part: 05.000.008, synthes lot #: 006774, previous synthes lot #: 005243, supplier lot #: 005243, release to warehouse date: 02 jul 2013, 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: the customer reported the 05.000.008 reverse does not work.The repair technician reported the device bearings were grinding and there is debris on the inside.The device did not run in fast forward, forward, or reverse.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 will be repaired and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived in 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) 2020 the handpiece for battery powered driver reverse did not work.The issue was observed during a weekly audit.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).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Service and repair evaluation: the customer reported the 05.000.008 reverse does not work.The repair technician reported the device bearings were grinding and there is debris on the inside.The device did not run in fast forward, forward, or reverse.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 will be repaired and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 20.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 history lot: part 05.000.008.Synthes lot # 006775.Previous synthes lot # 005243.Supplier lot # 005243.Release to warehouse date: 02 jul 2013.Supplier: (b)(4).No ncr's were generated during production.Device history review: 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.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.

• 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
• MDR Report Key: 11154082
• MDR Text Key: 226567400
• Report Number: 2939274-2021-00172
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10887587024585
• UDI-Public: 10887587024585
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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: 006775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1