MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 11G IVAS ACCESS CANNULA; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Catalog Number	0306330000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the needle/cannula broke off in the patient and the case was not completed.Medical intervention was necessary by enlarging the pedicle hole to remove the device material left behind.A surgical prolongation was reported.Upon follow up, it was reported that the device was successfully removed from the patient.It was further reported that the patient was doing well and no additional procedure is planned at this time.
Event or Problem Description
It was reported that during the procedure, the needle/cannula broke off in the patient and the case was not completed.Medical intervention was necessary by enlarging the pedicle hole to remove the device material left behind.A surgical prolongation was reported.Upon follow up, it was reported that the device was successfully removed from the patient.It was further reported that the patient was doing well and no additional procedure is planned at this time.
Event or Problem Description
It was reported that during the procedure, the needle/cannula broke off in the patient and the case was not completed.Medical intervention was necessary by enlarging the pedicle hole to remove the device material left behind.A surgical prolongation was reported.Upon follow up, it was reported that the device was successfully removed from the patient.It was further reported that the patient was doing well and no additional procedure is planned at this time.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.

• Brand Name: 11G IVAS ACCESS CANNULA
• Common Device Name: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13549554
• Report Number: 3015967359-2022-00347
• Device Sequence Number: 5257009
• Product Code: OAR
• UDI-Device Identifier: 37613252505991
• UDI-Public: 37613252505991
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 02/02/2023

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: 0306330000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown