MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 LACTOSORB SYSTEM 1.5 X 4 MM DIRECT DRIVE LACTOSORB SCREW; BONE SCREW

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2017

Event Type  Injury  

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 three screws broke during the "operation of the upper screw." attempts have been made and no further information has been provided.

Manufacturer Narrative

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

Event Description

It was reported the screws fractured at or near the head of the screw.The surgeon replaced the broken screws.There was a five minute delay.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The 1.5x 4mm dir-drv lact scw 2pk (part# 915-2215, lot# 990590) was returned in a red biohazard bag.The screws were removed for visual inspection.One screw had some red residue on its head and a small piece broken off the head.All three were clearly fractured on the body of the screw.The screws were not functionally tested because they were returned in a biohazardous condition and there was obvious damage to them.Device history record (dhr) was reviewed and no discrepancies were found.There are no indications of manufacturing defects.The instructions for use (ifu) for this product states in the section titled warnings: improper selection, placement, positioning, or fixation of the implant can cause a subsequent undesirable result.Devices should not be located directly under a suture site.The surgeon is to be familiar with the devices, the method of application and the surgical procedure prior to performing surgery.Investigation results concluded that the reported event was due to excessive force during insertion.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.

Event Description

This report is being submitted to document the results of the device evaluation.

• Brand Name: 1.5 LACTOSORB SYSTEM 1.5 X 4 MM DIRECT DRIVE LACTOSORB SCREW
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7518909
• MDR Text Key: 108416357
• Report Number: 0001032347-2018-00276
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• PMA/PMN Number: PK012409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 915-2215
• Device Lot Number: 990590
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention