MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SCP FOOT & ANKLE KIT ACCUMIX SYSTEM; BONE GRAFT DELIVERY KIT

Catalog Number	514.303
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the surgical tech tried to reattach the sleeve to the stem which caused the sleeve to break, rendering the stem unable to push the contents up the cylinder.A different kit was opened, mixed and implanted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Visual examination of the provided photograph identified that the top of the plunger sleeve has fractured off.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed via provided photograph.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SCP FOOT & ANKLE KIT ACCUMIX SYSTEM
• Common Device Name: BONE GRAFT DELIVERY KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 56 e bell dr.; warsaw IN 46582
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 56 e. bell dr.; warsaw IN 46582
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22105311
• Report Number: 3008812173-2025-00002
• Device Sequence Number: 12601663
• Product Code: OJH
• UDI-Device Identifier: 00889024205345
• UDI-Public: (01)00889024205345(17)250901(10)209524222
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2025
• Device Catalogue Number: 514.303
• Device Lot Number: 209524222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female