MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ACM KIT W/ FEMORAL BREAKAWAY NOZZLE & PROX. MED. PRESS.; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0306573000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure at the user facility the nozzle of the cement mixing bowl was not able to be connected properly causing a detachment and finally a leakage of cement out the gun and therefore it had to be applied by hand.The procedure was completed by placing the cement by hand; no medical intervention or adverse consequences have been reported.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.H3 other text: not available.
Event or Problem Description
It was reported that during a procedure at the user facility the nozzle of the cement mixing bowl was not able to be connected properly causing a detachment and finally a leakage of cement out the gun and therefore it had to be applied by hand.The procedure was completed by placing the cement by hand; no medical intervention or adverse consequences have been reported.

• Brand Name: ACM KIT W/ FEMORAL BREAKAWAY NOZZLE & PROX. MED. PRESS.
• Common Device Name: MIXER, CEMENT, FOR CLINICAL USE
• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17164620
• Report Number: 3015967359-2023-01328
• Device Sequence Number: 5757682
• Product Code: JDZ
• UDI-Device Identifier: 34546540055416
• UDI-Public: 34546540055416
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Followup
• Report Date (Section B): 11/03/2023

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: 0306573000
• Device Lot Number: 23024012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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