MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM STRAIGHT PLATE-EXTENDED - 4 HOLE; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4), (b)(4).Foreign country: (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 the plate fractured during surgery.The procedure was completed with another plate of the same size.It is stated the surgical technique was not followed.Attempts have been made and no further information has been provided.

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 plate cannot 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.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.

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.

Event Description

Additional information was received; it was reported during neuro surgery the plate fractured when the surgeon was fixing the screws.It was confirmed no broken parts were left in the patient.In regards to the surgical technique not being followed, the distributor stated this was a mistake when completing the complaint form.

• Brand Name: 2.0 LACTOSORB SYSTEM STRAIGHT PLATE-EXTENDED - 4 HOLE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8159679
• MDR Text Key: 130183818
• Report Number: 0001032347-2018-00866
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K971870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2023
• Device Model Number: N/A
• Device Catalogue Number: 915-2111
• Device Lot Number: 423250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR