MAUDE Adverse Event Report: SYNTHES GMBH AIR OSCILLATOR; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 511.610

Device Problems Noise, Audible (3273); Complete Loss of Power (4015)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported by (b)(6) that during service and evaluation, it was determined that the air oscillator device was making excessive noise.It was determined that the device was worn with cosmetic damage, had component damage to thread saw blade coupling, illegible etch, insufficient/low power and air leak.It was further determined that the device failed pretest for general condition, marking and labeling, checking saw blade quick coupling, checking for noticeable noise, checking oscillation frequency with frequency meter and checking for air leak.It was noted in the service order that the device did not work.It was reported there were no delays to the surgical procedure and the surgery was completed as intended.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition of excessive noise identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to component failure from wear.Udi: (b)(4).

• Brand Name: AIR OSCILLATOR
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 13226907
• MDR Text Key: 287708038
• Report Number: 8030965-2022-00225
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819110793
• UDI-Public: 07611819110793
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: EXEMPT
• 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: 11/01/2021

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 Catalogue Number: 511.610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Initial Date Manufacturer Received: 12/27/2021
• Initial Date FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2010
• 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