MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SITE P-LCK 2.9X 15.5; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP SITE P-LCK 2.9X 15.5
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/23/2020
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.
Event or Problem Description
It was reported that the anchor broke when impacted and one piece has been left in the patient.The broken off piece has not been retrieved and will remain in the patient.There was no harm for patient, operator or third party reported.No further information received.Update 15-jan-2021: the shoulder arthroscopy took place on (b)(6) 2020.There was no harm for patient, operator or third party reported.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.No further information received.
Additional Manufacturer Narrative
It was reported that the anchor broke during insertion.The reported event is confirmed upon investigation of the returned product.Visual evaluation identified no apparent malfunction to the assembly of each pushlock.The finished assembly should slide smoothly, and both devices were able to do so.Additionally, one anchor was received and found to be broken with debris in the threads.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: BIO-COMP SITE P-LCK 2.9X 15.5
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11228669
• Report Number: 1220246-2021-02495
• Device Sequence Number: 3861716
• Product Code: MAI
• UDI-Device Identifier: 00888867023024
• UDI-Public: 00888867023024
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: BIO-COMP SITE P-LCK 2.9X 15.5
• Device Catalogue Number: AR-1923BC-1
• Device Lot Number: 10300661
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other