MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ACCUPORT SIDE-DEL 11GA X 120MM; FILLER, BONE VOID

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
The subchondroplasty side delivery cannula broke inside a patient whilst drilling by the user.This resulted in a 20 minute delay in surgery whilst the surgeon removed the broken tip from the patients bone.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h6 (health effect - impact code).
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ACCUPORT SIDE-DEL 11GA X 120MM
• Common Device Name: FILLER, BONE VOID
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: leo munar ; 841 springdale drive; exton, PA 19341 ; 4848794553
• MDR Report Key: 13088312
• Report Number: 3008812173-2021-00007
• Device Sequence Number: 5926585
• Product Code: MQV
• UDI-Device Identifier: 00889024205116
• UDI-Public: (01)00889024205116(17)260405(10)47972
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2022

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: 04/05/2026
• Device Model Number: N/A
• Device Catalogue Number: 307.032
• Device Lot Number: 47972
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 01/13/2022; 01/13/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 01/21/2022; 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown