MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM OMNIMAX SD XD SCREW 2.0X9MM; SCREW, FIXATION, INTRAOSSEOUS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/24/2022

Event Type  Injury  

Event Description

It was reported that during a procedure the screw fractured.The patient retained a fragment of the device.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 #: 91-5709, lot # ni, traumaone system omnimax sd xd screw 2.0x9mm.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: 0001032347-2022-00128.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned screw.The screw shows signs of attempted use including marking on the screw heads.The screw shaft has fractures in the bone thread section.A dimensional analysis cannot be conducted due to the damage to the screw.The complaint is confirmed.A determination cannot be made as to what caused the screw to fracture.Lot identification is necessary for review of device history records, lot identification was not provided.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.

Event Description

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

• Brand Name: TRAUMAONE SYSTEM OMNIMAX SD XD SCREW 2.0X9MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 14462664
• MDR Text Key: 292368484
• Report Number: 0001032347-2022-00129
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

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: 91-5709
• 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: 04/25/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 06/02/2022
• Supplement Dates FDA Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White