MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC OSCILLATING MICRO SAW; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number O-SAW

Device Problems Detachment of Device or Device Component (2907); Complete Loss of Power (4015)

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

Event Type  malfunction  

Event Description

It was reported from switzerland that during service and evaluation, it was determined that the oscillating saw attachment device fell apart and was loose.It was further determined that the device failed pretest for visual assessment.It was noted in the service order that the device had a damaged hose.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Additional narrative: the device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device was received in two pieces hanging together and the parts could be separated without further manipulation of the screws.Both screws were loosened but functional.When the attachment was tested with local equipment, the device oscillated well.Regular signs of wear could be detected on interior mechanics.Therefore, the reported condition was confirmed.The assignable root cause was traced to component failure due to normal wear.A device history review was performed, and no non-conformances were detected related to the reported condition.Udi: (b)(4).

• Brand Name: OSCILLATING MICRO SAW
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 15076504
• MDR Text Key: 296981405
• Report Number: 1045834-2022-00917
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00845384005612
• UDI-Public: 00845384005612
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2022

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: O-SAW
• Device Catalogue Number: O-SAW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2019
• 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