MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH MENISCAL REPAIR DEVICE STRAIGHT; FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE

Catalog Number	110024772
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: taiwan 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
It was reported that when opening the packaging of the product, the sterile packaging was damaged, exposing the first blue rivet.There was no reported harm to the patient.Multiple attempts have been made to obtain additional information.No additional information has been received at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6 he following sections were corrected: d9; h6 visual examination of the returned product identified the first anchor is out of the tip and has not been cycled.However, the device was not returned in original packaging.Therefore, device manipulation cannot be ruled out.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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
It was reported that when the product was opened the implant was prematurely outside of the needle already.There was no report of damage to the sterile packaging.

• Brand Name: JUGGERSTITCH MENISCAL REPAIR DEVICE STRAIGHT
• Common Device Name: FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE
• 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: 20706257
• Report Number: 0001825034-2024-02701
• Device Sequence Number: 9604162
• Product Code: MBI
• UDI-Device Identifier: 00880304690066
• UDI-Public: (01)00880304690066(17)260416(10)637700
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/16/2024

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 Expiration Date: 04/16/2026
• Device Catalogue Number: 110024772
• Device Lot Number: 637700
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2021
• 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