MAUDE Adverse Event Report: STRYKER ENDOSCOPY FORMULA AGGRESSIVE PLUS; ACCESSORIES, ARTHROSCOPIC

Catalog Number 375-544-000

Device Problems Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/10/2016

Event Type  malfunction  

Event Description

During procedure, while using the shaver device, the metal shaver pieces appeared to dislodge from the shaver with small pieces entering the surgical cavity.A new shaver was utilized.The area was irrigated and pieces of metal were removed.

• Brand Name: FORMULA AGGRESSIVE PLUS
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct.; san jose CA 95138
• MDR Report Key: 6166303
• MDR Text Key: 62133017
• Report Number: 6166303
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2016,11/14/2016

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
• Device Operator: Physician
• Device Catalogue Number: 375-544-000
• Device Lot Number: 5079175
• Other Device ID Number: 4.0 MM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 74