MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5MM BARREL 180MM LONG HIGH VIS; SAW, POWERED, AND ACCESSORIES

Model Number	72203131
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during use the burr 5.5mm barrel 180mm long high vis systematically released metal into the patient.The metal debris was cleaned up.The procedure was completed with a s+n back up device.It is unknown if there was a delay and an unknown patient injury was reported.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history 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.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A visual inspection revealed the device was returned in sealed packaging.A visual inspection revealed the device was free of damage.A functional evaluation revealed the device functions as intended clockwise, counter clockwise, and while oscillating.There was no shedding during functional testing.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 5.5MM BARREL 180MM LONG HIGH VIS
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11948572
• Report Number: 1643264-2021-02081
• Device Sequence Number: 4243288
• Product Code: HAB
• UDI-Device Identifier: 00885554025514
• UDI-Public: 00885554025514
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2023
• Device Model Number: 72203131
• Device Catalogue Number: 72203131
• Device Lot Number: 50909741
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention