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

Model Number	IOBP HIP OPEN TIP PROCEDURE KIT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1220246-2022-04419
• Device Sequence Number: 19260907
• Product Code: FMF
• UDI-Device Identifier: 00888867338548
• UDI-Public: 00888867338548
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/07/2022
• Date Device Manufactured: 05/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown