MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 11G X 20MM OMNICURVE FRACTURE KIT; ARTHROSCOPE

Model Number 1032-120-000

Device Problem Fracture (1260)

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

Event Date 06/27/2023

Event Type  malfunction  

Event Description

It was reported that the product became stuck in hard bone and upon removal, it broke.A screw removal set was used to remove the piece that was stuck in the hard bone.It should be noted that the procedure was completed successfully, with no patient impact, no surgical delays, and without any adverse consequences.

• Brand Name: 11G X 20MM OMNICURVE FRACTURE KIT
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17316709
• MDR Text Key: 319124061
• Report Number: 3015967359-2023-01440
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327554663
• UDI-Public: 07613327554663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1032-120-000
• Device Catalogue Number: 1032-120-000
• Device Lot Number: 8574720
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1