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

Catalog Number 00234702044

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: (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.Product not returned.

Event Description

It was reported that when the screw was implanted, it collided with the pre-implanted screw.After inspection, the screw thread was confirmed to be damaged, the doctor removed the damaged screw and replaced it with an intact screw.There was no patient injury reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1, b4, b5, d4, d8, e1, e2, e3, g2, g3, g6, h2, h3, h4, h6, h10.Corrected: h6: device code.The event could not be confirmed as no product or photographs were received.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to user error: the screw was placed in the direction of deviation.The surgical technique states: ¿apply the appropriate drill guide to one of the nonlocking shaft slots, and use the appropriate standard drill to drill through both cortices.Use the depth gauge to measure the appropriate screw length.Then insert a self-tapping lag screw.Check the position of the screw with the fluoroscope.Repeat this procedure for each of the nonlocking screws to be inserted.If both locking and nonlocking screws will be used in the shaft, the nonlocking screws must be inserted first." if the drill, guide, and fluoroscope was utilized correctly, the screws should not have hit each other.Additionally, as it was noted that this was 5th screw implanted, all screws implanted prior must also be nonlocking screws or this deviated to technique too.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: 10992499
• MDR Text Key: 221515814
• Report Number: 0002648920-2020-00523
• 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
• Report Date: 04/29/2021

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: 00234702044
• Device Lot Number: 63873768
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR