MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC 2.9MM; SPORTS MED IMPLANTS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 110010384, toggleloc 2.9mm, lot # 207280r.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.A medcial investigation was done and it was found that procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.A stroke can happen to anyone at any time.It occurs when blood flow to an area of brain is cut off.When this happens, brain cells are deprived of oxygen and begin to die.Stroke is also known as the following: cva (cerebral vascular accident), tia (transient ischemic attack) and brain infarction.There are two classifications of stroke.A hemorrhagic stroke is when a brain aneurysm bursts or a weakened blood vessel leaks.An ischemic stroke occurs when a blood vessel carrying blood to the brain is blocked by a blood clot which can be cardiogenic due to underlying atrial fibrillation or from anti- or hypercoagulants which change the viscosity of the blood.A perioperative stroke is a serious and rare complication that may occur when a patient undergoes a surgical procedure and typically requires medical intervention.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02105 h3 other text : remains implanted.
Event or Problem Description
It was reported a patient underwent a right bicep tenodesis approximately 2 years ago.Subsequently, a month afterwards, the patient experienced a stroke and went through stroke rehab.Treatment is unknown.During the visit about 4 months ago, the patient was progressing well and reported regularly participating in active events.Attempts have been made and there is no further information at this time.

• Brand Name: TOGGLELOC 2.9MM
• Common Device Name: SPORTS MED IMPLANTS
• 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: 17712344
• Report Number: 0001825034-2023-02104
• Device Sequence Number: 19395898
• Product Code: JDR
• UDI-Device Identifier: 00880304812864
• UDI-Public: (01)00880304812864(17)230121(10)868910R
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: N/A
• Device Catalogue Number: 110010384
• Device Lot Number: 868910R
• 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: 08/14/2023
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 54 KG