MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X50MM CANNULATED TRANSLATION SCREW; SPINAL FIXATION SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
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.Reference report 3012447612-2021-00094.
Event or Problem Description
It was reported that the tip of a screwdriver broke on the last of 8 screws during an l3-s1 lumbar spinal fusion.The screw was removed and replaced using another driver.The screw and fragments were removed.There was no reported patient impact.This is report 2 of 2 for this event.
Event or Problem Description
It was reported that the tip of a screwdriver broke on the last of 8 screws during an l3-s1 lumbar spinal fusion.The screw was removed and replaced using another driver.The screw and fragments were removed.There was no reported patient impact.This is report 2 of 2 for this event.
Additional Manufacturer Narrative
Additional information in a3 and h6: component codes, type of investigations, findings, and conclusions.Device evaluation: visual inspection revealed the tip of the inserter has fractured off the driver and is stuck inside the screw.Potential cause root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied to the driver during screw insertion.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.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: 5.5 TI 6.5X50MM CANNULATED TRANSLATION SCREW
• Common Device Name: SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11614567
• Report Number: 3012447612-2021-00095
• Device Sequence Number: 3049192
• Product Code: NKB
• UDI-Device Identifier: 00880304948990
• UDI-Public: (01)00880304948990(10)2642381
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K123549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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 Model Number: N/A
• Device Catalogue Number: 14-571450C
• Device Lot Number: 2642381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Patient Age: 64 YR
• Patient Weight: 80