MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X5MM HT SD X-DR SCREW; PLATE, BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/20/2023

Event Type  Injury  

Event Description

It is reported that during a procedure while placing a trephination plate with screws, that three of the screws fractured creating the need to place the plate in another area.There was a surgical delay and three fragments of the screws remained within the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: item# 91-6105, lot# j935280, 1.5x5mm ht sd x-dr screw qty 2.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00068 and 001032347-2023-00070.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the three returned screws.All three screw show signs of attempted using including marking/ scratching on the screw heads.All three screws have fractured screw shafts.The screw tips were not returned.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.This report is being submitted to update additional information in section b4, b5, d9, g3, g6, h2, h3, h4, h6 and h10.

Event Description

No further event information is available at the time of this report.

• Brand Name: 1.5X5MM HT SD X-DR SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16584182
• MDR Text Key: 311695132
• Report Number: 0001032347-2023-00069
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036053741
• UDI-Public: (01)00841036053741(10)J935280
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 91-6105
• Device Lot Number: J935280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other