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

Catalog Number 7205000000

Device Problem Unintended Power Up (1162)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

Device not yet received.

Event Description

It was reported by that the trigger was sticking, which has the potential to cause run-on.No patient involvement and no surgical delay were reported with this event.Additional information has been requested from the user facility.

Manufacturer Narrative

The reported event was confirmed through the evaluation service process but no run-on was found.

Event Description

It was reported by that the trigger was sticking, which has the potential to cause run-on.No patient involvement and no surgical delay were reported with this event.Additional information has been requested from the user facility.

• Brand Name: SYSTEM 7 DUAL TRIGGER ROTARY
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5830049
• MDR Text Key: 50659599
• Report Number: 0001811755-2016-01327
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1