MAUDE Adverse Event Report: SYNTHES GMBH OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 511.801

Device Problems Complete Loss of Power (4015); Excessive Heating (4030)

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

Event Date 11/24/2021

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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition of the device generating heat identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to component failure due to wear.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that oscillating attachment device was generating heat and making excessive noise.It was further observed that the device had cosmetic damage, worn seal and worn bearing.It was further determined that the device failed pretest for general condition, marking and labeling, and checking the oscillation frequency with frequency meter.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.

• Brand Name: OSCILLATING SAW ATTACHMENT II
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 13444785
• MDR Text Key: 290538653
• Report Number: 8030965-2022-00655
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 07611819102262
• UDI-Public: 07611819102262
• 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: 11/24/2021

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: 511.801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2019
• 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