MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 11G 10MM IVAS ELITE SINGLE KIT; ARTHROSCOPE

Catalog Number	0808110000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the access cannula was being used in a kyphoplasty and when the doctor tried to remove the device part of the distal tip of the outer shaft broke off in the bone.The broken off tip was left in the vertebral body.Another surgeon tried to remove the access cannula and eventually decided to leave it in the bone.
Event or Problem Description
It was reported that the access cannula was being used in a kyphoplasty and when the doctor tried to remove the device part of the distal tip of the outer shaft broke off in the bone.The broken off tip was left in the vertebral body.Another surgeon tried to remove the access cannula and eventually decided to leave it in the bone.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.

• Brand Name: 11G 10MM IVAS ELITE SINGLE 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: 19047262
• Report Number: 3015967359-2024-00617
• Device Sequence Number: 8482813
• Product Code: HRX
• UDI-Device Identifier: 37613327142700
• UDI-Public: 37613327142700
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K181752
• 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): 05/22/2024

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: 0808110000
• Device Lot Number: 23164012
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/22/2024
• 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: Required Intervention
• Patient Sex: Unknown