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

Catalog Number	1032-120-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : discarded by customer.
Event or Problem Description
It was reported that the delivery device separated during the procedure and there is a possibility that some of the sheath remained in the pedicle, although it cannot be confirmed.It should be noted that the procedure was completed successfully without any medical intervention, surgical delays, or adverse consequences.

• Brand Name: 11G X 20MM 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: 17548778
• Report Number: 3015967359-2023-01830
• Device Sequence Number: 6657633
• Product Code: HRX
• UDI-Device Identifier: 07613327554663
• UDI-Public: 07613327554663
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K162062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2023

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 Catalogue Number: 1032-120-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 08/15/2023
• 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
• Patient Sex: Unknown