MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH STRAIGHT IMPLANT; FASTENER, FIXATION

Model Number	110024772
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a sports medicine repair procedure, the tip of the juggerstitch implant fractured.There was no surgical delay or patient impact as a result of the malfunction.Due diligence is in progress for this event, to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).G2: foreign: germany.Diligence is in progress to determine whether the product will be returning to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated:b4; d9; g3; h2; h3; h6; h10.The following section has been corrected: b5.Visual examination of the returned product identified the green handle and needle have fractured.The device was cycled once.The reported event has been confirmed through product return.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during a meniscal repair procedure, the tip of the inserter fractured during placement of the second anchor.No adverse events have been reported as a result of the malfunction.Due diligence is complete as multiple attempts have been made however it was reported that no further information is available.

• Brand Name: JUGGERSTITCH STRAIGHT IMPLANT
• 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: 16918284
• Report Number: 0001825034-2023-01045
• Device Sequence Number: 20543192
• Product Code: MBI
• UDI-Device Identifier: 00880304690066
• UDI-Public: (01)00880304690066(17)271108(10)65707735
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191459
• 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): 08/13/2023

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: 110024772
• Device Catalogue Number: 110024772
• Device Lot Number: 65707735
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose