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

Catalog Number 05.000.008

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 07/12/2023

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.D2: additional procodes: hxx, 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.Synthes lot # 008191.Supplier lot # 008191.Release to warehouse date # 09 jun 2022.Supplier # triangle manufacturing.No ncrs were generated during production.The customer reported that the 05.000.008 hand piece for battery powered reverse does not work.The repair technician reported that the device ran intermittently in fast forward condition, wires were discolored, brown residue on the motor and the barriers.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 the inspection sheet, passed synthes final inspection on (b)(6) 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 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) 2023 during routine equipment check, it was discovered that the driver in question would not run in reverse.There was no reported patient or procedure involvement.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, 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: 17550096
• MDR Text Key: 321181219
• Report Number: 8030965-2023-10314
• 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: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.000.008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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