MAUDE Adverse Event Report: MEDLINE RENEWAL STRYKER; FORMULA¿ BARREL BUR, 6-FLUTE(BLUE/BLUE)-USE W/CORE/CROSSFIRE/CROSSFIRE2 V1.0.04

Catalog Number	375951100RH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during use on a shoulder arthroscopy procedure, the reprocessed stryker formula¿ barrel bur, 6-flute (blue/blue)-use w/core/crossfire/crossfire2 v1.0.04 or prev.5.0mm released metal shavings.It is unknown what medical intervention was required to retrieve the reported metal shavings.Per report, "i would assume they did a flush w/ the arthroscopy joint, and no particles remained inside of the patient." there was no serious injury or adverse patient consequence reported related to this event.Due to the reported issue of the device releasing metal shavings and the reported required medical intervention, this medwatch is being filed.The sample was returned for evaluation and the complaint was confirmed.The lot number associated with the device was not reported.A review of the reprocessing record could not be performed.A potential root cause is end-user applying side force to the shaver.A definitive root cause for the reported issue could not be confirmed at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the reprocessed stryker formula¿ barrel bur was releasing metal shavings during shoulder arthroscopy.

• Brand Name: STRYKER
• Common Device Name: FORMULA¿ BARREL BUR, 6-FLUTE(BLUE/BLUE)-USE W/CORE/CROSSFIRE/CROSSFIRE2 V1.0.04
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 9119185
• Report Number: 3032391-2019-00022
• Device Sequence Number: 10857828
• Product Code: HRX
• UDI-Device Identifier: 10888277381025
• UDI-Public: 10888277381025
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

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 Catalogue Number: 375951100RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/25/2019
• 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