MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X7MM HT SD X-DR SCR EA; SCREW, FIXATION, BONE

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (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 five out of eight screws broke intraoperatively during a cranioplasty.There was a surgical delay of approximately 15-20 minutes and some of the screw tips remain in the patient's skull.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed as visual inspection noted damage to the screw heads and that the screws were fractured along the threaded portion of the screw shafts.It was reported that some of the screw tips remained in the skull, therefore these were not returned.Also reported is that 5 out of the 8 screws used fractured; since only two were available for return, there weren't any functional testing or inspections able to be performed on the three screws that were not returned.For the part #91-6107 and the previous year (from the notification date) regarding the screws fracturing intraoperatively, there is a complaint rate of 0.11% which is no greater than the occurrence listed in the application fmea.Based on this information the most likely underlying cause of the complaint is that they experienced force in excess of what they were designed to encounter; it is possible that the screws were over torqued or the patient had high bone density, but this cannot 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 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.

• Brand Name: 1.5X7MM HT SD X-DR SCR EA
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8708497
• MDR Text Key: 148322656
• Report Number: 0001032347-2019-00328
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K121624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• 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: 91-6107
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention