MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD; SCREW, FIXATION

Catalog Number 00234702040

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Information (3190)

Event Date 10/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that when the screw was implanted, it collided with a previously implanted screw.The damaged screw was removed and replaced.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h3, h4, h6, h10.Device history record was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to user error: the screw was placed in the direction of deviation, and the force was too strong, which caused the screw thread to be damaged.This is addressed on page 16 of periarticular distal tibial locking surgical technique (97-2347-046-00) stating, "check the position of the screw with the fluoroscope.Repeat this procedure for each of the non-locking screws to be inserted." a summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: CORTICAL BONE SCREW SELF-TAPPING HEX HEAD
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10992559
• MDR Text Key: 220969841
• Report Number: 0002648920-2020-00525
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K142579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00234702040
• Device Lot Number: 63867265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR