MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,32MM LGTH, STRL; BONE FIXATION SCREW/PLATE

Model Number COMPR FT SCRW,2.5 MICRO,32MM LGTH, STRL

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 8/15/2023, it was reported by a sales representative via sems that an ar-8737-37 driver shaft, 1.5 mm hex, cannulated, had an issue.The driver tip broke in the comp ft screw and would not come out.This was discovered during an unspecified time on (b)(6) 2023.No case/patient involvement.Additional information was requested.On 8/25/2023, the sales representative stated the following information via phone: this occurred during use in a dip fusion procedure.The instrument was not used with power.The broken driver tip was removed from a micro comp ft screw 32mm, but the screw was damaged and could not be inserted fully.It also could not be removed by the surgeon, so it was left inside the patient but was not seated fully flush.There was no deviation from the intended procedure, and the procedure was completed.This caused a two-hour case delay, and additional anesthesia had to be administered to the patient.Additional information was requested.On 8/29/2023, the sales representative provided the following information via email: the lot number for the micro 32mm screw was not available.It could not be confirmed if a second surgery would be needed.

• Brand Name: COMPR FT SCRW,2.5 MICRO,32MM LGTH, STRL
• Type of Device: BONE FIXATION SCREW/PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17709919
• MDR Text Key: 322932655
• Report Number: 1220246-2023-07818
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COMPR FT SCRW,2.5 MICRO,32MM LGTH, STRL
• Device Catalogue Number: AR-8725-32HS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other