MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB SYSTEM 14MM RAPID FLAP; BONE PLATE

Model Number N/A

Device Problems Fracture (1260); Unstable (1667)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Report source: 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 that a rapidflap lb cranioplasty was performed, and at the time of starting to lower one of the cymbals of the system, the pole was split between the two cymbals.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is that the clamps kept turning and did not achieve fixation.The distributor reported that the clamps remained implanted.No product was returned and no functional tests or inspections could be performed.For these reasons, the complaint could not be verified and the most likely underlying cause of the complaint could not be determined.There are no indications of manufacturing defects.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The lactosorb rapidflap clamp (part #915-0020, lot #unknown) was visually inspected.The post was found to be fractured in two places.The majority of the post was left in tact in the applier, while a short section broke off and was stuck inside the outer plate, which indicates the post broke while the outer plate was being threaded down into position on the post.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to excessive force while screwing the outer plate onto the post.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.The surgeon is to be familiar with the device, the method of application and the surgical procedure prior to performing surgery.The devices can break or be damaged due to excessive activity, load bearing upon insertion in vivo, or trauma.This could lead to failure of the device, which could require additional surgery and/or device removal.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

Additional information was provided.The distributor reported "we returned only one that was the one that was removed because it broke and we returned it for study, the other two the specialist left implanted despite being loose.".

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional event details were provided on may 8, 2018.

• Brand Name: LACTOSORB SYSTEM 14MM RAPID FLAP
• Type of Device: BONE PLATE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7444036
• MDR Text Key: 105946512
• Report Number: 0001032347-2018-00214
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: PK003281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 915-0020
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00841036053864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention