MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.; SAW, POWERED, AND ACCESSORIES

Model Number	72203127
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case: (b)(4).
Event or Problem Description
It was reported that there was a hair in the hub of the abrader burr.Incident occurred while setting-up to a hip procedure.A back-up device was available and no significant delays occurred.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned in a plastic bag without the original packaging.There was some debris on the device and in the bag.The bag contained a loose hair, but its source could not be determined since it was separated from the device and original packaging.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the packaging found that the parts are inspected for embedded particulates, loose particulates, and contaminants of human origin.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11676274
• Report Number: 1219602-2021-00876
• Device Sequence Number: 3015548
• Product Code: HAB
• UDI-Device Identifier: 03596010655899
• UDI-Public: 03596010655899
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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: 05/01/2023
• Device Model Number: 72203127
• Device Catalogue Number: 72203127
• Device Lot Number: 50903172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1