MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AO SMALL DRILL; ARTHROSCOPE

Model Number 4100110000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

The user facility reported that the device fell apart during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Event Description

The user facility reported that the device fell apart during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

H3 other text : device not returned.

• Brand Name: AO SMALL DRILL
• 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: 12840168
• MDR Text Key: 280999060
• Report Number: 3015967359-2021-02602
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540068156
• UDI-Public: 04546540068156
• 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: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4100110000
• Device Catalogue Number: 4100110000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2022
• 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