MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PD SERIES MAESTRO PERFORATOR CHUCK; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number 5400210060

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 03/18/2019

Event Type  malfunction  

Event Description

It was reported that part of the chuck was stuck on the drill during cleaning.There was no patient involvement reported with this event.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a root cause could not be determined for the event.Device not returned.

Event Description

It was reported that part of the chuck was stuck on the drill during cleaning.There was no patient involvement reported with this event.

• Brand Name: PD SERIES MAESTRO PERFORATOR CHUCK
• Type of Device: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 8515715
• MDR Text Key: 141978613
• Report Number: 0001811755-2019-01196
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 04546540469229
• UDI-Public: 04546540469229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041754
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5400210060
• Device Catalogue Number: 5400210060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2017
• 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