MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4.0MM CANC LOCK SCREW 32MM; FASTENER, FIXATION

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 110030400, prx hum hi plt rt 3h 80mm, lot # unknown.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00868.

Event Description

It was reported that the surgeon has a locking screw head passed through the plate.Screw was removed and replaced with multi-directional screw and tightened with torque limiting screwdriver until click indicated proper torque was reached.Screw hole in plate was the most proximal anterior hole in the plate.Attempts have been made and there is no further information at this time.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed as visual examination of the returned product identified the head of the screw was damaged.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The plate was not returned or pictures provided; visual and dimensional evaluations could not be performed.A device history record review was not completed as a limited investigation was completed; also the lot identification was not provided.A definitive root cause could not be determined.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.

• Brand Name: 4.0MM CANC LOCK SCREW 32MM
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11565610
• MDR Text Key: 245463830
• Report Number: 0001825034-2021-00867
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K143697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 816140032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1