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

Model Number	375-544-000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was not returned to medline renewal for evaluation, therefore we were unable to confirm that the device was reprocessed.Although the device was not returned we performed 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 root cause of the tip detachment could not be determined at this time.Per the device's instructions for use (ifu), if a rotating shaver or bur touches another surgical instrument during activation, then device integrity and effectiveness may be compromised.In the event that contact occurs, the user should inspect the tip before proceeding.Additionally, the ifu warns users that increased pressure or side loading of the blade during will not improve the performance of the instrument and that it can dull the blade or cause other damage.Although no patient harm was reported, medical intervention was required by the surgeon to retrieve the detached tip; therefore medline renewal is filing this medwatch report.(b)(4).Device not returned for evaluation.
Event or Problem Description
Medline renewal received a report indicating that the tip of the reprocessed stryker formula aggressive plus cutter, model 375-544-000, broke off in the patient's shoulder during use.The tip was retrieved by the surgeon, and did not result in patient harm.Another device was readily available to complete the procedure; therefore no 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: 6088246
• Report Number: 3032391-2016-00035
• Device Sequence Number: 818305
• Product Code: HRX
• UDI-Device Identifier: 10888277379855
• UDI-Public: 10888277379855
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 11/08/2016

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: 02/28/2019
• Device Model Number: 375-544-000
• Device Lot Number: 287374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2016
• Initial Report FDA Received Date: 11/08/2016
• 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