MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BARREL ABRADER,POWER-MINI, DISP,2.9; SAW, POWERED, AND ACCESSORIES

Catalog Number	72201520
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery when using the device, after connecting the device to the handpiece, the cutter does not protrude beyond the protection tube and is therefore unusable.To compensate for the incident, a second device of the same reference and different batch was used without success; then a third device of the same reference and a third batch also without success.The surgeon continued the procedure manually using a curette.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Two 2.9 mm power mini abrader burrs were returned for evaluation.Visual assessment of the devices showed no abnormalities.Devices were tested using a dyonics power mini mdu and found to function as intended.Dimensional assessment of each device confirmed the components are within print specifications.Reported complaint could not be confirmed.An exact root cause cannot be determined with confidence without the return of the device, however, factors that could have contributed to the reported event include: damage to the mdu.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BARREL ABRADER,POWER-MINI, DISP,2.9
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9056684
• Report Number: 1219602-2019-01113
• Device Sequence Number: 2450245
• Product Code: HAB
• UDI-Device Identifier: 03596010656049
• UDI-Public: 03596010656049
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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 Expiration Date: 09/15/2021
• Device Catalogue Number: 72201520
• Device Lot Number: 50759017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 09/14/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1