MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION FACIAL PLATING SYSTEM; SCREW, BONE, 1.5 X 4 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE SCREW

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Device Damaged by Another Device (2915)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Because the lot number is unknown, the device history records could not be pulled and reviewed.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It is reported that during a case that occurred the week of (b)(6) 2017, the surgeon was unable to tighten the screws into the unknown htr implant.The screws stripped and kept turning into the implant and did not gain purchase.The surgeons pre-drilled holes and fixated the implant using plates and 4mm screws from the neuro set.In this case, the surgeon had to use emergency screws in two of the holes and then placed mesh over the htr implant in order to fixate it.More information was requested but has not been received at this time.

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 complaint is that the screw stripped, kept turning in the implant and did not gain purchase.No product was returned and no functional tests or inspections could be performed.Review of the complaint history determined that no further action is required as no trends were identified.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following sections were updated: date of this report, date received by manufacturer, type of report and follow-up number, follow-up type, device evaluated by manufacturer and not returned to manufacturer, additional narratives/data.

• Brand Name: BIOMET MICROFIXATION FACIAL PLATING SYSTEM
• Type of Device: SCREW, BONE, 1.5 X 4 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE 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: 6804519
• MDR Text Key: 83039420
• Report Number: 0001032347-2017-00678
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-6104
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2018
• 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: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention