MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIOBLASTER,4.0MM,EP-1,DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	7205668
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign post code - (b)(6).
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the blade heated up and vibrated with a strange noise.A back-up device was available to complete, without delay, the procedure.The patient did not experience any adverse consequence.
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the motor drive unit heated up and vibrated with a strange noise.A back-up device was available to complete, without delay, the procedure.The patient did not experience any adverse consequence.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.
Additional Manufacturer Narrative
The initial incident report was submitted with incorrect manufacturing site information and registration number 1219602 (s+n mansfield).The correct manufacturing site information and registration number is 1643264(s+n oklahoma).Corrected data: d3 and g1 manufacturing site name, address and contact information.

• Brand Name: ACROMIOBLASTER,4.0MM,EP-1,DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8643131
• Report Number: 1219602-2019-00604
• Device Sequence Number: 1975340
• Product Code: HAB
• UDI-Device Identifier: 03596010293084
• UDI-Public: 03596010293084
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup,Followup
• Report Date (Section B): 02/08/2020

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 Expiration Date: 03/30/2023
• Device Model Number: 7205668
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 50724367
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 07/04/2019; 07/18/2019; 02/08/2020
• Initial Report FDA Received Date: 05/26/2019
• Supplement Report FDA Received Date: 07/01/2019; 07/19/2019; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1