MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW; BONE SCREW

Model Number N/A

Device Problems Separation Failure (2547); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Age and patient sex: clarification was requested as the patient was originally reported as a (b)(6) female and the additional information states patient is a young male.Concomitant medical product: biomet microfixation lactosorb system 1.5mm self-drilling lactosorb tap, dense bone catalog #: 915-1590-01 lot #: 780750.Therapy date: (b)(6) 2017.Report source: foreign country - (b)(6).Customer has indicated that this product will not be returned to zimmer biomet for investigation, it remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00084.

Event Description

It was reported that while placing the screw in the zygomatic region, "the surgeon could not fix the screw completely and wrench off the hex head although the surgeon attempted to insert the screw after using both taps.The surgeon stated that diameter of both taps were more large than the traditional tap.The surgery was completed after remained hex head of screws were melted using heat pen." there was no surgical delay.No adverse events have been reported as a result of the malfunction.In response to requests for additional information the customer reported the patient's bone was expected dense because the patient was young male.The surgeon experienced difficulty removing the hex head on four screws.It is unknown if the tap created larger holes or if bigger screws were needed as a result.It was confirmed the screws were fixed fully using the heat pen.

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.Visual inspection and functional testing could not be performed due to the products not being returned, therefore the complaint cannot be verified and the most likely underlying cause cannot be determined.The difficulty wrenching off the hex head was likely due to the inability to fixate the screw properly.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.The tap involved in this event, which was reported in 0001032347-2018-00084, was returned and the evaluation is in progress.(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00084-2.

Event Description

The customer confirmed the patient is a (b)(6) female.

• Brand Name: 1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 7331360
• MDR Text Key: 102211105
• Report Number: 0001032347-2018-00120
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK002083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 915-2316
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01) 0 0841036 05519 6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR