MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4205000000

Device Problem Unintended Power Up (1162)

Patient Problem No Information (3190)

Event Date 09/17/2014

Event Type  malfunction  

Event Description

It was reported that at the user facility the trigger of the device was getting stuck in the on position, a condition which caused the device to run without user activation.Upon follow up, the user facility was not able to provide any further information regarding the reported event.

Manufacturer Narrative

The reported run-on was confirmed by a manufacturer repair technician through functional evaluation.Upon disassembly, a broken pin was found, which can lead to the reported event.

• Brand Name: SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-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: 4172398
• MDR Text Key: 5156623
• Report Number: 0001811755-2014-03612
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4205000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Date Manufacturer Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2006
• 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