MAUDE Adverse Event Report: JACE MEDICAL T15 HEXALOBE DRIVE SILVER; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number 201.047.15

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/24/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 a silver screw bit was fractured and retained by a patient during a procedure.There was no delay as the fracture was not noticed until after the case.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d8; g3; g4; g6; h1; h2; h3; h6; h10 h3: no product was returned and insufficient information was provided.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.The root cause of the reported issue is attributed to a user error.It was reported that a surgeon used the ez system without the torque limiter on accident and stripped the silver bit (201.047.15).Per the surgical technique for this system, the torque limiter must be used.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.

Event Description

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

• Brand Name: T15 HEXALOBE DRIVE SILVER
• Type of Device: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): JACE MEDICAL; 3516 commerce drive; warsaw IN 46580
• Manufacturer (Section G): JACE MEDICAL; 3516 commerce drive; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17161959
• MDR Text Key: 317547926
• Report Number: 3010906386-2023-00024
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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 Catalogue Number: 201.047.15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other