MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 7-12 GH TOP; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a tasp fractured into two pieces.The surgeon attempted to impact the trial into a tight joint space.Attempts to obtain additional information have been made; however, no more information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual examination of returned product found it exhibits signs of repeated use and the lateral side of the tasp has fractured off.All pieces were returned.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.Root cause was determined to be due to user error as the persona surgical technique (97-5026-001-00 rev.13, page 39) instructs that gentle manual pressure should be applied without impacting the tasp construct with either a mallet or hand.Closely following this technique tip should decrease the risk of any tasp construct failures.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: CR TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 7-12 GH TOP
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12673707
• Report Number: 0001822565-2021-03033
• Device Sequence Number: 19192983
• Product Code: JWH
• UDI-Device Identifier: 00889024245037
• UDI-Public: (01)00889024245037(10)63638477
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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 Model Number: N/A
• Device Catalogue Number: 42527000610
• Device Lot Number: 63638477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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