MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPTIGHT ANKLE SYN FIXATION-TI ION TI; FASTENER, FIXATION

Model Number	904759
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the during the surgery, hair like debris was found inside the sterile package.Another product was used to complete the surgery.No adverse event has been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).Report source: foreign- japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded by the hospital as biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Device discarded by the hospital.
Event or Problem Description
No additional event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 ANKLE SYN FIXATION-TI ION TI
• Common Device Name: FASTENER, FIXATION
• 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: 15162896
• Report Number: 0001825034-2022-01763
• Device Sequence Number: 12381012
• Product Code: JDR
• UDI-Device Identifier: 00880304476103
• UDI-Public: (01)00880304476103(17)261015(10)746550
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 904759
• Device Catalogue Number: 904759
• Device Lot Number: 746550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown