MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X36MM LOW PRO CORT SCR STE; SCREW, FIXATION

Catalog Number 851235036

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Information (3190)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6) 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

It was reported that during the procedure, the screw could not be inserted fully due to the patient's bone quality.The screw was removed and found to be deformed.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the screw was bent and the head was damaged.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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.

Event Description

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

• Brand Name: 3.5X36MM LOW PRO CORT SCR STE
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8392075
• MDR Text Key: 137940376
• Report Number: 0001825034-2019-00972
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K111663
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 851235036
• Device Lot Number: DPMBT2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN ALPS TIBIA PLATE
• Patient Outcome(s): Hospitalization; Required Intervention