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

Catalog Number	0206710000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure at the user facility that part of the inserter attachment became lodged in the femoral canal and broke after multiple attempts to remove it.Surgeons were unable to remove it, leaving 5 cm of the inserter tool within the femur.X-ray was completed to ensure no injury/fracture to femur occurred.The procedure was completed successfully; no further medical interventions were reported.Multiple attempts were made to obtain additional information.The user facility was not able to provide any further information regarding the reported event.

• Brand Name: BIO-PREP BONE PREPARATION KIT
• Common Device Name: PROTHESIS, 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: 22226309
• Report Number: 3015967359-2025-01120
• Device Sequence Number: 15607635
• Product Code: JDK
• UDI-Device Identifier: 04546540039637
• UDI-Public: (01)04546540039637(17)300301(10)25080012
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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
• Device Catalogue Number: 0206710000
• Device Lot Number: 25080012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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