MAUDE Adverse Event Report: ARTHREX, INC. IOBP HIP OPEN TIP PROCEDURE KIT; SYRINGE, PISTON

Model Number IOBP HIP OPEN TIP PROCEDURE KIT

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2022

Event Type  malfunction  

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 (b)(6) 2022, it was reported by a sales representative via email that abs-2010-ot internal mechanism broke while the surgeon was trying to flip the flipcutter for a decompression.This was discovered during a procedure.No additional information provided.Additional information requested.Additional information received 1/24/2022: this was discovered during an iobp procedure.Device broke when surgeon tried to flip the flipcutter to decompress, there was a pop, and the flipcutter would not flip nor would it drill.This occurred during use; however no pieces came loose inside the patient.Surgeon was able to use a reamer to decompress the bone and complete case.

• Brand Name: IOBP HIP OPEN TIP PROCEDURE KIT
• Type of Device: SYRINGE, PISTON
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13471766
• MDR Text Key: 287804354
• Report Number: 1220246-2022-04419
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00888867338548
• UDI-Public: 00888867338548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121124
• 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: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IOBP HIP OPEN TIP PROCEDURE KIT
• Device Catalogue Number: ABS-2010-OT
• Device Lot Number: 13348143
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2022
• Date Device Manufactured: 05/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1