MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 11G X 15MM OMNICURVE FRACTURE KIT; ARTHROSCOPE

Catalog Number	1032-115-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure the doctor was unable to remove the trocar from the patient.After multiple attempts the device was removed in multiple pieces.It should be noted that the surgeon believes this was likely due to the patient's anatomy.The procedure was completed successfully and without or surgical delay.We are currently trying to gather some additional information from the customer as well.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.H3 other text : device is at the healthcare facility, it was never returned to stryker.
Event or Problem Description
It was reported that during the procedure the doctor was unable to remove the trocar from the patient.After multiple attempts the device was removed in multiple pieces.It should be noted that the surgeon believes this was likely due to the patient's anatomy.The procedure was completed successfully and without or surgical delay.They were able to remove the pieces from the patient successfully with surgical exploration.No additional incisions were needed.

• Brand Name: 11G X 15MM OMNICURVE FRACTURE KIT
• Common Device Name: 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: 19103977
• Report Number: 3015967359-2024-00658
• Device Sequence Number: 7407888
• Product Code: HRX
• UDI-Device Identifier: 07613327554496
• UDI-Public: 07613327554496
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1032-115-000
• Device Lot Number: 9239382
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown