MAUDE Adverse Event Report: MEDLINE RENEWAL ARTHROSCOPIC BUR; ARTHROSCOPIC ACCESSORY

Model Number	375-950-100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The facility reported metal shavings in the surgical site.Another device was readily available to complete the procedure.There was no report of adverse patient consequence, no effect on the patient's stability, and no need for additional medical intervention as a result of the incident.The device in question was returned for evaluation.We confirmed that the device had been reprocessed.The device was in good condition, and did not contain evidence of residual metal shavings.Our investigation could not confirm the reported issue, and therefore the root cause of the failure is unknown at this time.A review of the device history confirmed that all processes were conducted as required, and that the device met inspection and lubrication requirements prior to packaging and release.However, we are filing this medwatch report in an abundance of caution.
Event or Problem Description
A stryker formula¿ round bur left metal shavings in the patient's knee during the procedure.

• Brand Name: ARTHROSCOPIC BUR
• Common Device Name: ARTHROSCOPIC ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6175821
• Report Number: 3032391-2016-00044
• Device Sequence Number: 10866159
• Product Code: HRX
• UDI-Device Identifier: 10888277382855
• UDI-Public: 10888277382855
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K012667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

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: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: 375-950-100
• Device Lot Number: 280654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR