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 05/27/2022

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.Additional narrative: procode: additional product code: part#: 05.000.008, synthes lot#: 008169, supplier lot#: 008169, release to warehouse date: 19 may 2022, supplier : triangle manufacturing.No non conformance reports were generated during production.Service & repair evaluation: the customer reported that the device hand piece for battery powered driver all speeds barely work.The repair technician reported that contact plate was damaged, membrane vent and wires were discolored, found brown residue on the barriers, the device intermittently runs in forward & low run in fast forward and reverse conditions.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: circuit board, shrink tubing, motor/gearhead, cam screw, membrane switch/flex circuit, hand piece for battery and all applicable components.The item was repaired per inspection sheet, passed synthes final inspection on 9-feb-2023 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 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 may 27, 2022, during audit it was observed that the handle battery powered driver all speeds barely work.There was no patient consequences.There was no further information available.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 Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16503316
• MDR Text Key: 311484212
• Report Number: 8030965-2023-02856
• 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: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• 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: 008169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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