MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; ARTHROSCOPE

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 06/06/2017

Event Type  malfunction  

Event Description

While repairing acl in o.R.The stryker burr left metal shavings in the tissue.This was not a reprocessed unit.Name of product is as follows: stryker arthroscopic shaver blade.Ref 0375-951-000 exp.10/13/21.Burr is an aggressive 6-flute barrel bur 5.5mm x 125mm.

• Brand Name: N/A
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region ct.; lakeland FL 33815
• MDR Report Key: 6629452
• MDR Text Key: 77196365
• Report Number: 6629452
• Device Sequence Number: 1
• Product Code: HRX
• 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: 06/07/2017

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: No Information
• Device Expiration Date: 10/13/2021
• Device Model Number: N/A
• Device Catalogue Number: 375-951-000
• Device Lot Number: 16288CE2
• Other Device ID Number: (17)211013(10)16288CE2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2017
• 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 Age: 16 YR
• Patient Weight: 73