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	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
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
An arthrex employee has reported that during a shoulder arthroscopy the anchors broke into halve when they were inserted.The part remained inside the patient as it was properly fixated.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.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified that two fragments of biocomposite anchors were returned, measuring approximately 2.45mm and 3.77mm, respectively.No other anchor remnants were observed, neither loose or fitted at the end of the two received pushlock drive shafts.This event is most likely the result of improper bone preparation, and/or prying/leveraging during insertion.It was noted that the bone quality and method of bone preparation were not recorded.No abnormalities were identified with the two pushlock drive shafts.

• 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: 10379131
• Report Number: 1220246-2020-02009
• Device Sequence Number: 14239339
• Product Code: MAI
• UDI-Device Identifier: 00888867023024
• UDI-Public: 00888867023024
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: BIO-COMP SITE P-LCK 2.9X 15.5
• Device Catalogue Number: AR-1923BC-1
• Device Lot Number: 10716304
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other