MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CURVE VARIABLE INSERTER SHAFT; ZYSTON ARC INTERBODY SPACER

Catalog Number	14-533041
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a threaded variable inserter broke off into its mating implant under impaction.The implant with the tip was removed and replaced to complete the procedure.There was no reported patient harm.
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 tip of a threaded variable inserter broke off into its mating implant under impaction.The implant with the tip was removed and replaced to complete the procedure.There was no reported patient harm.
Additional Manufacturer Narrative
Corrections in d4: udi number and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation visual inspection revealed that the tip of the device fractured off and is retained in the mating cage in which it broke off.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review per dhr review, the part was likely conforming when it left zimvie control.Device use this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: CURVE VARIABLE INSERTER SHAFT
• Common Device Name: ZYSTON ARC INTERBODY SPACER
• 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: 13736988
• Report Number: 3012447612-2022-00061
• Device Sequence Number: 14583204
• Product Code: MAX
• UDI-Device Identifier: 00888480470182
• UDI-Public: (01)00888480470182(10)PT43A
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K110650
• 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): 07/14/2022

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: 14-533041
• Device Lot Number: PT43A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2012
• 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