MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPTIGHT AC JOINT 2 ZIPLOOPS; SPORTS MED IMPLANTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in the middle of the procedure when the implant was opened from the packaging, an inconsistency was noted in the loops, the surgeon generated tension to see if it could be resistant during the procedure, but it fractured.Therefore, another implant was used to complete the procedure.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).G2: colombia.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The reported event for suture loop inconsistency is unable to be confirmed.Visual examination of the returned product identified 2 suture groups were returned.One suture group was returned with the button attached and the sutures ends are frayed and damaged, indicating attempted use.The second suture group was returned without the button attached, indicating attempted manipulation.Both suture groups were laid out and determined to be knotted appropriately during manufacturing.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.

• Brand Name: ZIPTIGHT AC JOINT 2 ZIPLOOPS
• Common Device Name: SPORTS MED IMPLANTS
• 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: 19350349
• Report Number: 0001825034-2024-01276
• Device Sequence Number: 12620386
• Product Code: JDR
• UDI-Device Identifier: 00880304478824
• UDI-Public: (01)00880304478824(17)280207(10)0002497281
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K130033
• 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): 08/27/2024

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: 904835
• Device Lot Number: 0002497281
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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: 38 YR
• Patient Sex: Female