MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW; POLYMER, EAR, NOSE, AND THROAT, SYNTHETIC, ABSORBABLE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an open reduction procedure the hex screw head of the first screw was wrenched off before it was inserted into the patient's bone completely.The surgeon could not fix a second screw due to the idling of that screw.The surgery was completed using an emergency screw.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Functional testing and inspections could not be performed due to the parts not being returned and no photographs, x-rays, scans, or physician reports being provided.The instructions for use (ifu) for this product provides the following information 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.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW
• Type of Device: POLYMER, EAR, NOSE, AND THROAT, SYNTHETIC, ABSORBABLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8199786
• MDR Text Key: 131523350
• Report Number: 0001032347-2018-00896
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• PMA/PMN Number: K012409
• 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: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2023
• Device Model Number: N/A
• Device Catalogue Number: 915-2315
• Device Lot Number: 960000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1