MAUDE Adverse Event Report: STRYKER CORPORATION SYSTEM 7 DUAL TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 7205000000

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2017

Event Type  malfunction  

Event Description

Device will not hold power.

• Brand Name: SYSTEM 7 DUAL TRIGGER ROTARY HANDPIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct.; san jose CA 95138
• MDR Report Key: 6837546
• MDR Text Key: 84327614
• Report Number: 6837546
• Device Sequence Number: 1
• Product Code: HWE
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7205000000
• Device Catalogue Number: 7205000000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2017
• 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