MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1/4" DRILL WITH KEY; ARTHROSCOPE

Model Number 4100131000

Device Problem Ejection Problem (4009)

Patient Problems Laceration(s) (1946); Device Embedded In Tissue or Plaque (3165)

Event Date 03/02/2022

Event Type  malfunction  

Event Description

The user facility reported that the device ejected a bur during testing prior to a procedure.The user was cut on the forehead.There were no reported delays or medical interventions.

Manufacturer Narrative

Correction: d9, h3.Additional info h6 h3 other text : device not returned.

Event Description

The user facility reported that the device ejected a bur during testing prior to a procedure.The user was cut on the forehead.There were no reported delays or medical interventions.

• Brand Name: 1/4" DRILL WITH KEY
• Type of Device: ARTHROSCOPE
• 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 ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13967826
• MDR Text Key: 288314225
• Report Number: 3015967359-2022-00597
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540068170
• UDI-Public: 04546540068170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943323
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4100131000
• Device Catalogue Number: 4100131000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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