MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL SCREW, DIA. 6.5MM X 50MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 701M6550

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2023

Event Type  malfunction  

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 Description

It was reported that a vital screw could not be removed with the screwdriver or the stab & grab.A different instrument was used to complete the case.There was a 40-minute delay with no reported impact to the patient.The reason for removal is not currently known.

Manufacturer Narrative

If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported that the surgeon wanted to replace a screw to better fit the construct, however, it could not be removed with the screwdriver or the stab & grab.A different instrument was used to complete the case.There was a 40-minute delay with no reported impact on the patient.The reason for removal is not currently known.

Manufacturer Narrative

Corrections in h3.Additional information in 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 worn anodize on the tulip, material deformation on the threads within the tulip head as well as the threads on the screw shank.Gouges and scratches on the tulip head.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied on the implant during surgery dhr review: due to the scratches/damage to the device the lot number is not legible to be able to retrieve the dhr for review.Device usage: 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.

Event Description

It was reported that the surgeon wanted to replace a screw to better fit the construct, however, it could not be removed with the screwdriver or the stab & grab.A different instrument was used to complete the case.There was a 40-minute delay with no reported impact on the patient.The reason for removal is not currently known.

• Brand Name: POLYAXIAL SCREW, DIA. 6.5MM X 50MM
• Type of Device: VITALITY SPINAL FIXATION 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: 16926015
• MDR Text Key: 315230064
• Report Number: 3012447612-2023-00158
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 701M6550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCREWDRIVERS, UNKNOWN PART NUMBERS.
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic