MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPTIGHT AC JOINT 1 ZIPLOOP; 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	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: poland.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the suture from ziptight ac broke during the procedure.Attempts have been made and there is no further information at this time.
Event or Problem Description
It was further reported that on the primary surgery date approximately 3 months ago the x-rays showed correct positioning of the fragments.However, on the next day another x-ray was taken, and it showed that the bone fragments were now in incorrect positions.The patient was revised that day and fitted with a competitor's plate.The surgeon found a broken thread (without identifying which one) and it was discarded.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the surgical implements are correctly positioned at the superior clavicle and subcoracoid locations.The clavicle and coracoid are widely separated as noted.The widening of the ac joint is consistent with breakage of the ziptight suture.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 1 ZIPLOOP
• 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: 17247937
• Report Number: 0001825034-2023-01467
• Device Sequence Number: 6831382
• Product Code: JDR
• UDI-Device Identifier: 00880304478404
• UDI-Public: (01)00880304478404(17)271213(10)0002485188
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K130033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 904834
• Device Lot Number: 0002485188
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male