MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSCILLATING SAW; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	72204092
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device, which was not used in a procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual assessment was performed and showed due to the internal corrosion the device was unable to be disassembled.Functional inspection could not be performed.This device was manufactured in sept 2014.This failure is caused by wear from use.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that the oscillating saw has a unspecified failure.It is unknown whether the event happened during surgery and if there was a patient involvement.No further information available.Results of investigation revealed that during visual assessment the oscillating saw had internal corrosion which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: OSCILLATING SAW
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10592548
• Report Number: 3003604053-2020-00111
• Device Sequence Number: 19152922
• Product Code: GFA
• UDI-Device Identifier: 00885554033236
• UDI-Public: 885554033236
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72204092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1