MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO 10G IVAS ACCESS NEEDLE; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Catalog Number	0306530000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.1 device was labeled for single-use.1 device was not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale.Corrected data: h10 1 previously reported event is included in this follow-up record.Product return status 1 device was received.
Event or Problem Description
This report summarizes 1 malfunction event in which the device or cutting accessory fractured.- 1 event had patient involvement; no patient impact.

• Brand Name: 10G IVAS ACCESS NEEDLE
• Common Device Name: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• MDR Report Key: 11728517
• Report Number: 3015967359-2021-00529
• Device Sequence Number: 16898538
• Product Code: OAR
• UDI-Device Identifier: 37613252158784
• UDI-Public: 37613252158784
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 0306530000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/01/2021
• Supplement Date Received by Manufacturer: 01/01/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1