MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC SHAVER; ARTHROSCOPE 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	10/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to medline renewal for evaluation.Upon receipt, medline renewal confirmed the device had been reprocessed.Our evaluation confirmed that the device contained traces of metal shavings.Therefore, the reported issue was confirmed.It is unknown if the metal shavings were flushed from the site.Our investigation included both an inspection of the returned device, and a review of the device history record (dhr).We reconfirmed that all processes were conducted as required, and that the device met inspection and lubrication requirements prior to packaging and release.Unfortunately, the root cause of the device failure is unknown at this time.Per the device instructions for use (ifu), if a rotating shaver or bur contacts another surgical instrument during activation, device integrity and effectiveness may be compromised.Therefore in the event that contact occurs, the user should inspect the device before proceeding.There was no adverse patient consequences or additional medical intervention required as a result of the incident.However, due to the metal shavings and the reported delay in the procedure to obtain a new device, medline renewal is filing this medwatch report.
Event or Problem Description
Medline renewal received a report indicating that a reprocessed stryker formula" round bur, model 375-950-100, left metal shavings inside the surgical site during use.Another device was readily available to complete the procedure; therefore no patient harm or additional medical intervention was reported as a result of the incident.

• Brand Name: MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC SHAVER
• Common Device Name: ARTHROSCOPE ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6103076
• Report Number: 3032391-2016-00041
• Device Sequence Number: 1359736
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2016

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: 01/30/2019
• Device Model Number: 375-950-100
• Device Lot Number: 280654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2016
• Initial Report FDA Received Date: 11/15/2016
• 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: 14 YR