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

Catalog Number 72204092

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Date 07/14/2020

Event Type  malfunction  

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 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
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10592548
• MDR Text Key: 209223710
• Report Number: 3003604053-2020-00111
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00885554033236
• UDI-Public: 885554033236
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72204092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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