MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP AFB1120-AVAFLEX BALLOON¿11G 20MM; CEMENT, BONE, VERTEBROPLASTY

Model Number	1031120000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during cement injection of an l3 kyphoplasty, after the surgeon spot-filled clefted areas in the vertebral body, the curved needle could not be removed.Attempts to grasp the needle with a hemostat resulted in the needle breaking.The procedure was completed with an approximate 1-hour delay during which the needle was surgically cut down as close to the exit point of the pedicle as possible.No other medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Device not returned.

• Brand Name: AFB1120-AVAFLEX BALLOON¿11G 20MM
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• 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: 15579010
• Report Number: 3015967359-2022-01890
• Device Sequence Number: 20533322
• Product Code: NDN
• UDI-Device Identifier: 07613327374582
• UDI-Public: 07613327374582
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2022

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 Model Number: 1031120000
• Device Catalogue Number: 1031120000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0607-687-000 AUTOPLEX, UNKNOWN LOT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown