MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. SET SCREW DRIVER; NEXTGEN ALTIUS OCT SYSTEM

Catalog Number	14-525029
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that during final tightening of the cross-connector, the tip of the screwdriver and the screw of the cross-connector broke.There was a 40-minute delay without impact on the patient.This is report two of two for this event.
Additional Manufacturer Narrative
Corrections in d4: lot number, d9, and h3.Additional information in d4: udi number, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation the returned device matches the information in the complaint file and was examined.Visual inspection revealed a portion of the tip has fractured off.See attached images.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 usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that during final tightening of the cross-connector, the tip of the screwdriver and the screw of the cross-connector broke.There was a 40-minute delay without impact on the patient.This is report two of two for this event.

• Brand Name: SET SCREW DRIVER
• Common Device Name: NEXTGEN ALTIUS OCT SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17712060
• Report Number: 3012447612-2023-00260
• Device Sequence Number: 16703390
• Product Code: KWP
• UDI-Device Identifier: 00888480511328
• UDI-Public: (01)00888480511328(10)MMX1615
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K113593
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2023

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: 14-525029
• Device Lot Number: MMX1615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2014
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic