MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT 1.4MM SHRT W/NDLS; SPORTS MED INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the surgical needle of this complaint product was fractured during use.Therefore, the surgeon used a back up product for the surgery.No further information known.
Additional Manufacturer Narrative
(b)(4).G2: japan h3: 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.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, d2, g3, h1, h2, h3, h6, h11.Reported event was confirmed as visual examination of the returned product identified there were only 2 needles returned.No other pieces of the device were returned.One of the needles has been fractured and not all of the pieces were returned.There are also several gouges at the end of the needle near the fracture site.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: JUGGERKNOT 1.4MM SHRT W/NDLS
• Common Device Name: SPORTS MED INSTRUMENT
• 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: 19594402
• Report Number: 0001825034-2024-01667
• Device Sequence Number: 3980406
• Product Code: MBI
• UDI-Device Identifier: 00880304509641
• UDI-Public: (01)00880304509641(17)280218(10)0002500708
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110145
• 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): 11/05/2024

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: 912068
• Device Lot Number: 0002500708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2023
• 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 Sex: Unknown