MAUDE Adverse Event Report: BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK; BONE SCREW

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign.The event occurred in (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.Not returned to manufacturer.

Event Description

It was reported the screw did not function as intended during use.Another screw was used to complete the procedure without significant delay.It was stated in the initial reporting pre-holing with the drill may have contributed to the event.No further information is available at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.The 1.5x5mm ht x-drive screw 5/pk (part# 95-1505, lot# unknown) was visually evaluated and appeared to be in good condition overall.This screw is not a self-drilling screw and is designed to have grooves on the distal end running longitudinally down the shaft.There is mild discoloration of the screw at the grooves and threads on the distal end indicating an assertion attempt.The discoloration of the groove create an appearance that the screw threads might be damaged when it is not.The screw was functionally tested by inserting it into a block of white oak wood using a ratcheting screwdriver and blade.The screw inserted into the wood easily, therefore the complaint is unconfirmed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.There are no indications of manufacturing defects.The complaint was not confirmed.A summary of the investigation has been sent to the complainant.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 corrected data: d1 brand name was corrected from 1.5x5mm ht x-dr scr 5/pk to "1.5mm" system high torque (ht) cross-drive screw, 5/pk d2 common device name was corrected from plate, bone to bone screw d2 device product code was corrected from jey to hbw e1 address and phone number were corrected to reflect the hospital address and phone number g5 pma/510(k) number was corrected k121589 to reflect k121624.

Event Description

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

• Brand Name: "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7888794
• MDR Text Key: 120710010
• Report Number: 0001032347-2018-00647
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K121624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• 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: 95-1505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 01-7390 HANDLE, LOT UNK; 15-1196 BLADE, LOT UNK; 01-7390 HANDLE, LOT UNK; 15-1196 BLADE, LOT UNK