MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 8.5MM X 90MM MULTIAXIAL ILIAC SCREW; EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/18/2021

Event Type  Injury  

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 Description

It was reported that when the surgeon was driving the iliac screw into the hip plate, the head detached from the screw shaft.The head with the connecting ring remained on the screwdriver, while the shank of the screw remained screwed into the bone.The surgeon made attempts to unscrew the shaft but was unsuccessful and the screw shaft remains in the patient without posing a threat to her.A competitor's screw was used and screwed in next to the broken one in the bone.

Event Description

It was reported that when the surgeon was driving the iliac screw into the hip plate, the head detached from the screw shaft.The head with the connecting ring remained on the screwdriver, while the shank of the screw remained screwed into the bone.The surgeon made attempts to unscrew the shaft but was unsuccessful and the screw shaft remains in the patient without posing a threat to her.A competitor's screw was used and screwed in next to the broken one in the bone.While installing a different screw in the same procedure, the tulip lost polyaxial motion.It was removed and replaced with another screw without patient impacts.This is report one of two for this event.

Manufacturer Narrative

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 3012447612-2021-00031.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is confirmed via x-ray for one (1) of one (1) polaris multi-axial screw (pn 14-500336) for the failure of fracture.Medical records were not provided for review.Device evaluation: product has not yet been returned.However, x-rays were provided and can be used to confirm the screw fracture.Potential cause: root cause was unable to be determined as the product was not returned.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.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.

Event Description

It was reported that when the surgeon was driving the iliac screw into the hip plate, the head detached from the screw shaft.The head with the connecting ring remained on the screwdriver, while the shank of the screw remained screwed into the bone.The surgeon made attempts to unscrew the shaft but was unsuccessful and the screw shaft remains in the patient without posing a threat to her.A competitor's screw was used and screwed in next to the broken one in the bone.While installing a different screw in the same procedure, the tulip lost polyaxial motion.It was removed and replaced with another screw without patient impacts.This is report one of two for this event.

Event Description

It was reported that when the surgeon was driving the iliac screw into the hip plate, the head detached from the screw shaft.The head with the connecting ring remained on the screwdriver, while the shank of the screw remained screwed into the bone.The surgeon made attempts to unscrew the shaft but was unsuccessful and the screw shaft remains in the patient without posing a threat to her.A competitor's screw was used and screwed in next to the broken one in the bone.While installing a different screw in the same procedure, the tulip lost polyaxial motion.It was removed and replaced with another screw without patient impacts.This is report one of two for this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information and initially corrected information.The complaint is confirmed for one (1) of one (1) returned polaris multi-axial screw (pn 14-500336) for the failure of fracture.The complaint is confirmed for one (1) of one (1) returned polaris multi-axial screw (pn 14-500334) for the failure of lacking polyaxial motion.Medical records were not provided for review.Device evaluation: visual inspection of the devices reveals that item with lot number j3798377 has a fractured screw.Item with lot j3799069 is jammed in one position, with the screw unable to rotate.Lubrication of the device did not aid in this issue.Potential cause root cause was unable to be determined.It is possible that the screws were damaged due to patient conditions or other operational factors not detailed by the complainant.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: 8.5MM X 90MM MULTIAXIAL ILIAC SCREW
• Type of Device: EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11304168
• MDR Text Key: 231114038
• Report Number: 3012447612-2021-00011
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: K061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-500336
• Device Lot Number: J3798377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 01/22/2021; 04/08/2021; 04/12/2021
• Supplement Dates FDA Received: 02/15/2021; 04/09/2021; 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other