MAUDE Adverse Event Report: SYNTHES GMBH HAND PIECE FOR BATTERY POWERED DRIVER; SCREWDRIVER, SKULLPLATE

Model Number 05.000.008

Device Problem Mechanical Problem (1384)

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

Event Date 10/31/2022

Event Type  malfunction  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: additional product codes: hxx and hwe.Part # 05.000.008, synthes lot # 008074, supplier lot # 008074, release to warehouse date: 13 dec 2021, supplier: (b)(4).No non-conformance reports were generated during production.Service and repair evaluation: it was reported that the device 05.000.008 hand piece for battery powered driver all speeds were barely worked.There was no patient involvement.The repair technician reported discolored wires and membrane vent, black and brown residue on the barriers, rusted motor and device ran low in fast forward, forward & reverse condition.The following parts were replaced: circuit board, set screw, shrink tubing, hand piece housing, motor/gearhead, cam screw, membrane switch/flex circuit, holder/membrane vent, drive shaft rotary seal, hand piece for battery and all applicable components.The cause of the issue is unknown.Reason for repair is preventive maintenance.The item passed synthes final inspection on 14-nov-2022 and will be returned to the customer upon completion of the service and repair process attached service record router completed through operation 30.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 october 31, during weekly audit the hand piece for battery powered driver all speeds barely work.There was no patient involvement.This report is for one (1) hand piece for battery powered driver.This is report 1 of 1 for complaint (b)(4).

• Brand Name: HAND PIECE FOR BATTERY POWERED DRIVER
• Type of Device: SCREWDRIVER, SKULLPLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15983477
• MDR Text Key: 307745408
• Report Number: 8030965-2022-11106
• Device Sequence Number: 1
• Product Code: GXL
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2022

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: 008074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1