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

Model Number	BIOCOMPOSITE 2.4MM MINI HIP PUSHLOCK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2021
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 procedure, the surgeon was using the bio 2.4 mini hip pushlocks and the anchors broke upon using.Both shattered on the first tap with hammer.The correct drill and details were used performing the insertion of anchors according to manuel/technique guides.The case was completed by using a new ar-2924bch and ar-2924dh-2.
Additional Manufacturer Narrative
It was reported that the anchor broke.Visual evaluation identified from the picture that the anchor had broken.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.The reported event is confirmed based on the investigation of the returned picture.

• Brand Name: BIOCOMPOSITE 2.4MM MINI HIP PUSHLOCK
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11799051
• Report Number: 1220246-2021-03041
• Device Sequence Number: 1099290
• Product Code: MAI
• UDI-Device Identifier: 10888867311302
• UDI-Public: 10888867311302
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 05/13/2021

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: 10/31/2022
• Device Model Number: BIOCOMPOSITE 2.4MM MINI HIP PUSHLOCK
• Device Catalogue Number: AR-2924BCH
• Device Lot Number: 12032102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1