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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
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 an arthroscopy the device broke inside the patient.The broken pieces were retrieved from patient.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.*** update 14-aug-2023 nroemer: further information revealed that the tip of the device broke off.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1922bc was received for investigation.Upon visual inspection, it was noted that the returned device's inner tube tip was bent.No other issues were observed.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause for the reported failure is user error for applying excessive force during insertion or through leveraging/prying the device.

• 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: 17646118
• Report Number: 1220246-2023-07668
• Device Sequence Number: 7978863
• Product Code: MAI
• UDI-Device Identifier: 00888867022874
• UDI-Public: 00888867022874
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 12/26/2023

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: 15079772
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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