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

Catalog Number 511.610

Device Problems Output below Specifications (3004); Noise, Audible (3273); Complete Loss of Power (4015)

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

Event Date 02/18/2021

Event Type  malfunction  

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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error.Udi: (b)(4).

Event Description

It was reported by (b)(6) that during service and evaluation, it was determined that the power of the air oscillator device was insufficient/low, and the bearing and seal were worn.It was further observed that the device was making an excessive noise.It was further determined that the device failed pretest for check oscillating frequency with frequency meter and check for noticeable noise.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.

• Brand Name: AIR OSCILLATOR
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 11850624
• MDR Text Key: 251765475
• Report Number: 8030965-2021-04033
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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: 02/18/2021
• Date Manufacturer Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2016
• 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