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	09/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaver was providing multiple metalshavings.All visual metal parts were removed from the patient.No patient injuries were reported.
Additional Manufacturer Narrative
The blade was used.The physical condition of the returned device is good with exception of the burr head itself.This device has attained damages of a dinged or scraped nature on random cutting edges.The edges that should be sharp have sharp flat spots or missing material.The appearance is consistent with contact with a hard surface, another device or instrument.No root cause related to the manufacture of the device can be confirmed.Device evaluated by the manufacturer.Evaluation codes updated.

• Brand Name: ACROMIOBLASTER,4.0MM,EP-1,DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6875356
• Report Number: 1219602-2017-01158
• Device Sequence Number: 656289
• Product Code: HAB
• UDI-Device Identifier: 03596010293084
• UDI-Public: (01)03596010293084(17)211004(10)50624186
• 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: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2017

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 Model Number: 7205668
• Device Catalogue Number: 7205668
• Device Lot Number: 50624186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1