MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO THE MILL DISPOSABLE- COARSE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	5400703000
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that they found three plastic fragments, along with the bone chips from the patient's body during a procedure.The three plastics pieces were retrieve from the patient's body.There was no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The user facility reported that they found three plastic fragments along with the bone chips from the patient's body during a procedure.The three plastics pieces were retrieve from the patient's body.There was no delay, no medical intervention, and no adverse consequences.

• Brand Name: THE MILL DISPOSABLE- COARSE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• MDR Report Key: 10896754
• Report Number: 0001811755-2020-03284
• Device Sequence Number: 11514456
• Product Code: HWE
• UDI-Device Identifier: 34546540604126
• UDI-Public: 34546540604126
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5400703000
• Device Lot Number: 20188012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1