MAUDE Adverse Event Report: MEDLINE RENEWAL; STRYKER FORMULA¿ BARREL BUR, 6-FLUTE (RED/RED) 4.0MM

Catalog Number	375941000R
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a reprocessed stryker formula barrel bur had excessive metal shavings during use on a patient.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.There was no reported impact to the patient or to the procedure.Another device was opened and the procedure continued without further incident.There was no report of serious injury, adverse patient consequence or prolonged anesthesia related to the incident.Due to the reported incident and in an abundance of caution, renewal is filing this medwatch report.The sample was returned for evaluation and it was confirmed that the device was reprocessed.The reported issue that the inner shaft of the device contained metal shavings was confirmed.A root cause could not be determined at this time.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that reprocessed stryker formula barrel bur had excessive metal shavings.

• Common Device Name: STRYKER FORMULA¿ BARREL BUR, 6-FLUTE (RED/RED) 4.0MM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 7778102
• Report Number: 3032391-2018-00010
• Device Sequence Number: 173952
• Product Code: HRX
• UDI-Device Identifier: 10888277380899
• UDI-Public: 10888277380899
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2018

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: 02/28/2021
• Device Catalogue Number: 375941000R
• Device Lot Number: 380882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/13/2018
• 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: Other