MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP AVAFLEX CURVED NEEDLE W/ CANNULA; ORTHOPEDIC CEMENT INJECTION CANNULA

Catalog Number	1025011000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure the doctor was having a difficult time removing the avaflex device which lead to the handle snapping off.The avaflex was cut just under the skin and implanted with cement.Per the doctor the patient will need a revision surgery.The procedure was completed successfully.

• Brand Name: AVAFLEX CURVED NEEDLE W/ CANNULA
• Common Device Name: ORTHOPEDIC CEMENT INJECTION CANNULA
• 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20621696
• Report Number: 3015967359-2024-02308
• Device Sequence Number: 18030640
• Product Code: OAR
• UDI-Device Identifier: 07613327374612
• UDI-Public: (01)07613327374612(17)260320(10)9545146
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/06/2024

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: 1025011000
• Device Lot Number: 9545146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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