MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. INFIX ENDPLATE INSERTER LARGE; INFIX ANTERIOR LUMBAR SYSTEM

Catalog Number	1850-2500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported that the attachment tip of an endplate inserter was found broken prior to use during surgery.The inserter from a second set was used to complete the procedure without patient impacts.
Event or Problem Description
It was reported that the attachment tip of an endplate inserter was found broken prior to use during surgery.The inserter from a second set was used to complete the procedure without patient impacts.
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed the tip of the end plate has fractured off.Potential cause this event could possibly be attributed to wear through use over time or multiple sterilization cycles.The cause of the damage cannot be determined at this time since there is no information available regarding how the endplate inserter was being used or handled at the time of shipment or storage.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control initially.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: INFIX ENDPLATE INSERTER LARGE
• Common Device Name: INFIX ANTERIOR LUMBAR SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12226797
• Report Number: 3012447612-2021-00268
• Device Sequence Number: 3165109
• Product Code: MAX
• UDI-Device Identifier: 00889024402409
• UDI-Public: (01)00889024402409(10)1498597
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K132790
• 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): 02/23/2022

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: 1850-2500
• Device Lot Number: 1498597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• 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: 06/29/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male