MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORDLESS DRIVER 3 HANDPIECE; ARTHROSCOPE

Catalog Number 4300000000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2018

Event Type  malfunction  

Event Description

The device screw head to the battery plate was found to be missing during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

The device screw head to the battery plate was found to be missing during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.

• Brand Name: CORDLESS DRIVER 3 HANDPIECE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8189818
• MDR Text Key: 131171953
• Report Number: 0001811755-2018-02865
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613154641284
• UDI-Public: 07613154641284
• Combination Product (y/n): N
• PMA/PMN Number: K943323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4300000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1