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

Model Number 05.000.008

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 proceeds: gxl, hwe 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.Part #: 05.000.008 synthese lot #:008004 supplier lot #:008004 release to warehouse date: 14 dec 2020 suppliers: triangle manufacturing no ncr's generated during production.Service and repair evaluation: the customer reported that in 05.000.008, hand piece for battery powered driver, fast speed & reverse do not work consistently.The repair technician reported that the device did not run in fast forward, ran intermittently in forward, wires were discolored, brown residue was present on motor, barriers and circuit board.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: circuit board, shcs, pfhs, motor/gearhead barrier, membrane switch and flex circuit and all other applicable components.The item was repaired per the inspection sheet, passed synthese final inspection on 09-feb-2023 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, during audit it was observed that the handle battery powered driver fast speed & reverse do not work consistently.There were no patient consequences.No further information is available.This report is for a 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): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16564946
• MDR Text Key: 311681361
• Report Number: 8030965-2023-03290
• Device Sequence Number: 1
• Product Code: HXX
• 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

• 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: 008004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2020
• 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