MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH MENISCAL REPAIR DEVICE STRAIGHT; SPORTS MED INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Foreign Body In Patient (2687)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: poland.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : device discarded.
Event or Problem Description
It was reported that the patient underwent a magnetic resonance imaging (mri) due to unknown reasons.It was discovered that the patient had a metal body in the knee joint.No further details were given, except a photo which shows the retained fractured piece was removed on an unknown date.Attempts have been made and there is no further information at this time.
Event or Problem Description
It was reported a patient had an arthroscopic repair of the left meniscus approximately 11 months ago.Subsequently, it was found on radiographic imaging, a metallic foreign body remained by the meniscus and about 7 months later, underwent an additional surgery for removal of the retained foreign body.The surgery was completed without complication.
Additional Manufacturer Narrative
(b)(4).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
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as visual examination of the provided pictures identified a broken needle tip of a juggerstitch device after removal.Medical records/radiographs were provided and identified the following: it was reported a patient had an arthroscopic repair of the left meniscus about a year ago.Subsequently, it was found on radiographic imaging, a metallic foreign body remained by the meniscus 7 months later, underwent an additional surgery for removal of the retained foreign body.As the metal fragment was located behind the meniscus, it was not visible macroscopically.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.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, b6, d2, g3, h1, h2, h6.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The reported event is still confirmed by provided medical records.Medical records/radiographs were provided and identified the following: later follow ups confirmed the patient reports pain on the inside of the knee, slight exudate around the mcl, exudate under mcl and a cyst under mcl 1cm diameter.Ultrasound revealed thickened synovium and bursa reaction to the metallic foreign body, all other aspects of the knee well healed.Updated investigation results do not change the root cause; root cause remains 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
No further event information available at the time of this report.

• Brand Name: JUGGERSTITCH MENISCAL REPAIR DEVICE STRAIGHT
• Common Device Name: SPORTS MED INSTRUMENT
• 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: 18039501
• Report Number: 0001825034-2023-02541
• Device Sequence Number: 7531068
• Product Code: MBI
• UDI-Device Identifier: 00880304690066
• UDI-Public: (01)00880304690066(17)270929(10)467120
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup,Followup,Followup
• Report Date (Section B): 01/31/2025

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: 110024772
• Device Lot Number: 467120
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 11/09/2023; 02/12/2024; 07/01/2024; 01/30/2025
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/05/2023; 03/01/2024; 07/30/2024; 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• 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 Age: 24 YR
• Patient Sex: Female
• Patient Weight: 70 KG