MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED STRYKER FORMULA AGGRESIVE PLUS CUTTER; ARTHROSCOPIC SHAVER

Catalog Number 375-564-000

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 04/16/2014

Event Type  malfunction  

Event Description

During the use of arthroscopic shaver in shoulder arthroscopy surgical case, metal shavings could be seen in the shoulder.

• Brand Name: MEDLINE RENEWAL REPROCESSED STRYKER FORMULA AGGRESIVE PLUS CUTTER
• Type of Device: ARTHROSCOPIC SHAVER
• Manufacturer (Section D): MEDLINE RENEWAL; redmond OR
• MDR Report Key: 4387220
• MDR Text Key: 5429626
• Report Number: MW5039960
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 375-564-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2014
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 68