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 06/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the screw fractured after twisting it to insert it into the hole; this occurred prior to the final wrench of the screw.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.

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.The product was not returned for investigation and no photos were provided.For these reasons, the product could not be visually evaluated or functionally tested.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.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: 8153032
• MDR Text Key: 130071265
• Report Number: 0001032347-2018-00843
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2022
• Device Model Number: N/A
• Device Catalogue Number: 915-2315
• Device Lot Number: 255420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention