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

Model Number 4100131000

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

The user facility reported that the a drill bit broke and was left in the patient bone during a procedure.There was no medical intervention and no adverse consequences.

Manufacturer Narrative

Device not returned.

• 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: 13890252
• MDR Text Key: 287910837
• Report Number: 3015967359-2022-00559
• 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: K112593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: No
• 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