MAUDE Adverse Event Report: STRYKER 4MM AGGRESSIVE PLUS CUTTER; ARTHROSCOPY SHAVER

Catalog Number 375-544-000

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/14/2017

Event Type  Injury  

Event Description

Refurbished 4mm arthroscopic shaver tip broke off inside pt's shoulder capsule, broken piece of shaver retrieved.No apparent harm to the pt noted.

• Brand Name: 4MM AGGRESSIVE PLUS CUTTER
• Type of Device: ARTHROSCOPY SHAVER
• Manufacturer (Section D): STRYKER; tempe AZ 85283
• MDR Report Key: 6721377
• MDR Text Key: 80467261
• Report Number: MW5071045
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• 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: 07/14/2017

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 Expiration Date: 05/01/2020
• Device Catalogue Number: 375-544-000
• Device Lot Number: 6089210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR