MAUDE Adverse Event Report: ARTHREX, INC. 2.9MM BIOCOMP PUSHLOCK, DX; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	2.9MM BIOCOMP PUSHLOCK, DX
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2022
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 an ar-8923bc bio-composite pushlock suture anchor inserter broke inside the patient's bone.The impactor cap on the back of the pushlock broke before it met the purple plastic inserter body and a portion of the inserter somehow snapped within the patient's bone, while the anchor and eyelet was still able to be removed.The inserter broken fragment remains inside the patient.This was discovered during a procedure on (b)(6) 2022.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer-provided x-ray, where the broken inserter fragment is able to be visualized.However, without receipt of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: 2.9MM BIOCOMP PUSHLOCK, DX
• 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: 14192808
• Report Number: 1220246-2022-04766
• Device Sequence Number: 4975292
• Product Code: MAI
• UDI-Device Identifier: 00888867131491
• UDI-Public: 00888867131491
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• 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): 05/03/2022

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 Model Number: 2.9MM BIOCOMP PUSHLOCK, DX
• Device Catalogue Number: AR-8923BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown