MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	110024773N
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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 during a meniscal repair procedure, the suturing device anchor did not deploy.The correct surgical technique was used, and an alternate device was successfully used to complete the procedure without delay.No complications, injuries, or surgical interventions were required due to this malfunction.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Corrections to b5 and h6: additional information received indicated a deployment issue, with no additional details provided.As a deployment issue could indicate premature deployment or the anchor not deploying, the specific reported failure is unknown and cannot be determined.The reported event is not confirmed.Visual examination of the returned product identified the device has been cycled two (2) times and there are no sutures or anchors returned with the device.Product information cannot be confirmed as there is no etch and packaging was not returned with the device.A 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.Upon reassessment of the reported event, it was determined to be not reportable as the specific product failure could not be identified.The initial report was forwarded in error and should be voided.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 suturing device anchor experienced an unknown deployment issue.The correct surgical technique was used, and an alternate device was successfully used to complete the procedure without delay.No complications, injuries, or surgical interventions were required due to this malfunction.Attempts have been made, and no further information has been provided.

• Brand Name: JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 20263341
• Report Number: 0001825034-2024-02238
• Device Sequence Number: 12853125
• Product Code: MBI
• UDI-Device Identifier: 00887868575068
• UDI-Public: (01)00887868575068(17)281228(10)0930581
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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 Catalogue Number: 110024773N
• Device Lot Number: 0930581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2023
• 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