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

Model Number 375-950-100

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2016

Event Type  malfunction  

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 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
• Type of Device: ARTHROSCOPE ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer (Section G): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer Contact: brandi panteleon ; 2747 sw 6th st.; redmond, OR 97756 ; 5415164180
• MDR Report Key: 6103076
• MDR Text Key: 59906627
• Report Number: 3032391-2016-00041
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10888277382855
• UDI-Public: 10888277382855
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR