MAUDE Adverse Event Report: SYNTHES GMBH HAND PIECE FOR BATTERY POWERED DRIVER; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Catalog 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 11/29/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023 the hand piece for battery powered driver medium and reverse speed did not work.The issue was observed during weekly routine equipment check.There was no patient involvement.During manufacturer's investigation of the returned device it was identified that the contact pins gold film was damaged, white residue on switch plate, the device ran intermittently in fast forward, reverse conditions, did not run in forward condition.This report is for one (1) hand piece for battery powered driver this is report 1 of 1 for complaint (b)(4).

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.H10 additional narrative: h3, h6: service and repair evaluation: the customer reported the device 05.000.008 handle battery powered driver medium and reverse speed did not work.The issue was observed during weekly routine equipment check.The repair technician reported that the contact pins gold film was damaged, white residue on switch plate, the device ran intermittently in fast forward, reverse conditions, did not run in forward condition.The cause of the issue is unknown.The item will be repaired 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.H3, h4, h6: device history record (dhr) review conducted: part # 05.000.008 synthes lot # 007849 supplier lot # 007849 release to warehouse date: 26 jun 2020 supplier : triangle manufacturing no ncrs 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.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: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18580915
• MDR Text Key: 333739347
• Report Number: 8030965-2024-01356
• Device Sequence Number: 1
• Product Code: HWE
• 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: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.000.008
• Device Lot Number: 007849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2020
• 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