MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR, 5/PK 1.5X4MM TITANIUM; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that three screws were unable to insert consecutively/continuously into patient's cranium.The surgeon used iq driver.He completed the procedure using other screws.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The three screws were returned for investigation.The screws showed signs of use with a dull, rounded tip.Functional testing was done by attempting to insert the screws into a block of white oak wood using a ratcheting driver and blade.None of the screws were easily inserted into the wood, therefore the complaint is confirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: 1.5MM SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR, 5/PK 1.5X4MM TITANIUM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8470517
• MDR Text Key: 140539264
• Report Number: 0001032347-2019-00190
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036056650
• UDI-Public: 00841036056650
• Combination Product (y/n): N
• PMA/PMN Number: K121624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• 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: 95-6104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1