MAUDE Adverse Event Report: MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC SHAVER; ARTHROSCOPIC 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	05/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was not returned for evaluation.However, a picture of the device was provided by the user facility.We confirmed that the device was reprocessed and that the tip had detached.The lot number was also provided, and a review of the reprocessing records was performed.All processes were conducted as required prior to release.The reported issue was confirmed.The user facility confirmed that the tip was retrieved from the patient at the time of the procedure; however the incident extended the procedure time by approximately 10 minutes.A new device and a bag of fluid were required to complete the case.We do not have enough information to determine the root cause of the failure at this time, however if more information is provided then this report will be updated.There was no report of adverse patient consequence or additional medical intervention as a result of the incident.However, in an abundance of caution, we are filing this medwatch report.
Event or Problem Description
We received a report indicating that the tip of a reprocessed arthroscopic shaver detached during use.The physician was able to locate and remove the detached tip with a grasper.A new device and a bag of fluid were needed to complete the case.

• Brand Name: REPROCESSED ARTHROSCOPIC SHAVER
• Common Device Name: ARTHROSCOPIC ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave.; redmond OR 97756
• MDR Report Key: 6607354
• Report Number: 3032391-2017-00014
• Device Sequence Number: 530878
• Product Code: HRX
• UDI-Device Identifier: 10888277379855
• UDI-Public: 10888277379855
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: 375-544-000
• Device Lot Number: 338583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 06/02/2017
• 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: 56 YR
• Patient Weight: 79