MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS CPS ANCHOR PLUG 10MM; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 : foreign country : japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that when inserting the anchor plug drill bits, the drill bits fractured.There was a 1-2 hour delay due to the instrument fracture and adjusting the drill guide hole as the surgeon noted it to be deformed.The surgery was completed with the same anchor plug implant but they used drill bits from another anchor plug implant.No foreign bodies were retained.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
H6 : mechanical (g04) - drill.Visual examination of the returned product identified signs of use (nicked, gouged, scratches) and a fractured surface confirming the reported event.Device was submitted for further analysis.Analysis determined sem images of the fracture surface show sheared ductile dimples changing direction around the fracture surface.Fracture surface artifacts are consistent with torsional overload.Dimensional analysis of the product determined that the product was conforming to print specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were not provided.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMPRESS CPS ANCHOR PLUG 10MM
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19382392
• Report Number: 0001825034-2024-01343
• Device Sequence Number: 6341668
• Product Code: KWA
• UDI-Device Identifier: 00880304259690
• UDI-Public: (01)00880304259690(17)330727(10)497100
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043547
• 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
• Report Date (Section B): 10/11/2024

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: 178400
• Device Lot Number: 497100
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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
• Patient Age: 19 YR
• Patient Sex: Female