MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP AFB1115-AVAFLEX BALLOON 11G 15MM; ARTHROSCOPE

Catalog Number	1031115000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
In december 2023, stryker instruments received a copy of fda medwatch mw5148300.It was reported that during use in a kyphoplasty procedure at the user facility, the device fractured and a small piece of the device cannula tip remained embedded in the bone.It was reported that the surgeon extended an incision to evaluate and attempt retrieval of the cannula tip.This report will be filed to capture the new information regarding the incision.In 2021 stryker instruments filed original manufacturer report (b)(4) for the originally reported malfunction.

• Brand Name: AFB1115-AVAFLEX BALLOON 11G 15MM
• 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: 18495350
• Report Number: 3015967359-2024-00042
• Device Sequence Number: 3690657
• Product Code: HRX
• UDI-Device Identifier: 07613327374605
• UDI-Public: 07613327374605
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2024

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: 1031115000
• Device Lot Number: 6691323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 01/11/2024
• 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