MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP OPTABLATE 11G HAND DRILL PACK; SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY

Catalog Number	9700811000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between july 1 ¿ september 30 2025.This report summarizes 1 event for the failure: fracture.- 1 event had no health consequences or impact.
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 was not available for evaluation.Evaluation findings (results/components) 1 device: no findings available / part/component/sub-assembly term not applicable product disposition 1 device: product disposition is not yet determined additional information 1 device was labeled for single-use.1 device was not reprocessed or reused.

• Brand Name: OPTABLATE 11G HAND DRILL PACK
• Common Device Name: SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY
• 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 23368870
• Report Number: 3015967359-2025-99301
• Device Sequence Number: 12979319
• Product Code: OCJ
• UDI-Device Identifier: 07613327591552
• UDI-Public: 07613327591552
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• 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
• Report Date (Section B): 10/23/2025

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
• Device Catalogue Number: 9700811000
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown