MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. HARMONIC ACE; SCALPEL, ULTRASONIC, REPROCESSED

Model Number	HAR36
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The hand piece rotating mechanism was stiff and not twisting.The surgeon was unable to manipulate the device to use for the procedure.

• Brand Name: HARMONIC ACE
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 7312820
• Report Number: 7312820
• Device Sequence Number: 16606152
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347(17)180612106548
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2018
• Report Date (Section F): 02/21/2018

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: Physician
• Device Expiration Date: 06/12/2018
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: 6548988
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 02/21/2018