MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 5/32IN INCH DRILL WITH KEY; ARTHROSCOPE

Model Number	4100132000
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Codes	Laceration(s) (1946); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Additional info h6 h3 other text : device not returned.
Event or Problem 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: 5/32IN INCH DRILL WITH KEY
• Common Device Name: 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: 13967833
• Report Number: 3015967359-2022-00599
• Device Sequence Number: 12025290
• Product Code: HRX
• UDI-Device Identifier: 04546540068187
• UDI-Public: 04546540068187
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K943323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4100132000
• Device Catalogue Number: 4100132000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown