MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/2/2023, it was reported by an arthrex subsidiary employee via email that an ar-1922bc biocomposite pushlock anchor broke during insertion.All the broken fragments were removed, and the case was completed with a new ar-1922bc biocomposite pushlock from the same lot number.The case was delayed about five minutes, but no additional anesthesia was administered.This was discovered during an rcr procedure on 10/19/2023.
Additional Manufacturer Narrative
Review of this complaint confirmed the event summary code selection.The contribution of the device to the reported event could not be determined as the device was not available for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The most likely cause was determined to be use error.As no further investigation was able to be performed no change in harm was identified.Complaint trending for this event will be performed per wi-000100100.

• Brand Name: SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18226866
• Report Number: 1220246-2023-08969
• Device Sequence Number: 12097621
• Product Code: MAI
• UDI-Device Identifier: 00888867022874
• UDI-Public: 00888867022874
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

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: SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK
• Device Catalogue Number: AR-1922BC
• Device Lot Number: 15065269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown