MAUDE Adverse Event Report: ARTHREX, INC. BIOCOMPOSITE 2.4MM MINI HIP PUSHLOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIOCOMPOSITE 2.4MM MINI HIP PUSHLOCK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via sems that two ar-2924bch implants broke on insertion during a hip scope with a labral repair.The first implant broke on insertion.All was retrieved.A second implant was used in the same location and implanted fine.A third implant was used during this procedure but also broke during insertion.The top part broke off and it was retrieved.The remainder of the anchor stayed seated and the surgeon determined it had sufficient fixation therefore he elected to leave it in the patient.The procedure was completed with no further issues.The patient is fine to date.
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.

• Brand Name: BIOCOMPOSITE 2.4MM MINI HIP PUSHLOCK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 12983462
• Report Number: 1220246-2021-04081
• Device Sequence Number: 14510344
• Product Code: MAI
• UDI-Device Identifier: 10888867311302
• UDI-Public: 10888867311302
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201786
• 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): 12/13/2021

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: 03/31/2023
• Device Model Number: BIOCOMPOSITE 2.4MM MINI HIP PUSHLOCK
• Device Catalogue Number: AR-2924BCH
• Device Lot Number: 13082237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/13/2021
• Date Device Manufactured: 04/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown