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

Model Number	35ULT-ST-ZZ
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2016
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.Further evaluation found that the inner shaft was intact and the shaver was bent but not broken as per the initial report.The reported issue could not be confirmed.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 bent shaver 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.The customer confirmed that no adverse patient consequence or additional medical intervention was required as a result of the incident.Even though the device returned for evaluation was intact, medline renewal is filing this medwatch report in an abundance of caution.(b)(4).
Event or Problem Description
Medline renewal received a report indicating that the tip of the reprocessed linvatec ultracutdual purpose blade, model 35ult-st-zz, detached during a surgical procedure and was retrieved by the surgeon.The customer stated that 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: 6088196
• Report Number: 3032391-2016-00033
• Device Sequence Number: 1602486
• Product Code: HRX
• UDI-Device Identifier: 10888277354586
• UDI-Public: 10888277354586
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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: 09/30/2019
• Device Model Number: 35ULT-ST-ZZ
• Device Lot Number: 317043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2016
• 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