MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC ABRADER; ARTHROSCOPE ACCESSORY

Model Number	375-951-100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was not returned to medline renewal for evaluation.Our investigation included a review of the device history record, and we reconfirmed that all processes were conducted as required, and that the device met inspection requirements prior to packaging and release.The specific cause of the metal shavings could not be determined at this time.Due to the lack of information surrounding the incident, medline renewal does not have enough information to determine the root cause of the failure.The customer confirmed that no adverse patient consequence or medical intervention was required as a result of the incident.However, in an abundance of caution, medline renewal is filing this medwatch report.Device not returned for evaluation.
Event or Problem Description
Medline renewal received a report indicating that a reprocessed stryker formula barrel bur left metal shavings in the patient during a shoulder arthroscopy procedure.No adverse patient consequence was reported as a result of the incident.

• Brand Name: MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC ABRADER
• Common Device Name: ARTHROSCOPE ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6068233
• Report Number: 3032391-2016-00034
• Device Sequence Number: 813438
• Product Code: HRX
• UDI-Device Identifier: 10888277381025
• UDI-Public: 10888277381025
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K012667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2016

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: 08/30/2019
• Device Model Number: 375-951-100
• Device Lot Number: 314897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Initial Report FDA Received Date: 10/31/2016
• 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