MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP BIO-PREP BONE PREPARATION KIT; PROSTHESIS, HIP, CEMENT RESTRICTOR

Catalog Number	0206710000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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 8 events were reported for this quarter.Product return status 1 device was received.7 devices were not available for evaluation.Additional information 8 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 8 events for the failure: fracture.- 2 events had no health consequences or impact.- 6 events had insufficient information.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99051.Supplemental rationale, corrected data: b5, h6, h11.8 previously reported events were included in this follow-up record.Product return status.1 device was received.7 devices were not available for evaluation.Evaluation findings (results/components).1 device: fracture problem / inserter.7 devices: no findings available / part/component/sub-assembly term not applicable.Product disposition.1 device: scrapped by stryker.7 devices: product not received.
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 april 1 ¿ june 30, 2025.This report summarizes 8 events for the failure: fracture.- 2 events had no health consequences or impact.- 6 events had insufficient information.

• Brand Name: BIO-PREP BONE PREPARATION KIT
• Common Device Name: PROSTHESIS, HIP, CEMENT RESTRICTOR
• 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: 22587157
• Report Number: 3015967359-2025-99051
• Device Sequence Number: 21152906
• Product Code: JDK
• UDI-Device Identifier: 04546540039637
• UDI-Public: 04546540039637
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 8
• 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): 10/30/2025

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: 0206710000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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
• Patient Sex: Unknown