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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
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
It was reported that during a hip arthroscopic procedure with labral repair, the surgeon used the 2.4mm x 8.9mm biocomposite hip pushlocks, ar-2924bch and the first pushlock was implanted with no issues.The surgeon then used the ar-2924dhs-1 disposable kit to prepare the bone socket and there were qty.4 of the 2.4 hip pushlocks that cracked on the first impact.The surgeon prepared the bone socket exactly the same way and also took extra precaution to make sure the anchor was in line with the socket before malleting in the pushlock and cycled the drill each time to make sure there was not bone debris in the sockets.The material from each anchor that broke off was found and removed from the patient.The patient was not affected by the anchors breaking.The case was completed by using two 2.9mm hip pushlocks.

• 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
• MDR Report Key: 12267234
• Report Number: 1220246-2021-03459
• Device Sequence Number: 14564736
• 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): 08/03/2021

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: 07/12/2021
• Initial Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1