MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC WITH ZIPLOOP INLINE; 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	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant thread's fractured while being pulled on.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4) d10 - medical product: catalog #: 110005087, toggleloc with ziploop inline, lot # 0002442257 g2: india 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01183.
Additional Manufacturer Narrative
(b)(4).The reported event is unable to be confirmed as sutures said to have broken were not returned.Visual examination of the returned products identified the buttons only were returned with signs of damage and use.However, as the sutures said to have broken were not returned, further analysis could not be performed.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: TOGGLELOC WITH ZIPLOOP INLINE
• 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: 16992710
• Report Number: 0001825034-2023-01180
• Device Sequence Number: 6966013
• Product Code: JDR
• UDI-Device Identifier: 00880304567634
• UDI-Public: (01)00880304567634(17)261214(10)173850
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/08/2023

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: 110005087
• Device Lot Number: 173850
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Sex: Unknown