MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORDLESS DRIVER 4 HANDPIECE; INSTRUMENT, SURGICAL ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4405000000

Device Problem Failure to Shut Off (2939)

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

The reported event was duplicated.A service technician evaluated the device and observed that the trigger would stick, and run-on was observed.Upon disassembly, corrosion and wear were observed on the trigger assembly.The trigger assembly was replaced, preventative maintenance was performed, and the device was returned to the customer after passing final inspection.

Event Description

The device was returned to stryker instruments for service.During functional testing by a service technician, it was found that the reverse trigger was sticking and caused run on.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported.

• Brand Name: CORDLESS DRIVER 4 HANDPIECE
• 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: 5947839
• MDR Text Key: 54628886
• Report Number: 0001811755-2016-02200
• 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
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4405000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2014
• 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