MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-PUSHLOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTURE ANCHOR, BIO-PUSHLOCK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/28/2018
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 requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a shoulder arthroscopy when inserting into the drill channel the anchor was broken off.The surgeon tried to remove the piece from the patient but it was not removed.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 (b)(6) 05dec2018: the broken piece remains in the edge of the socket but firmly in the bone.It cannot move.A x-ray was not taken because it is in the bone.
Additional Manufacturer Narrative
The complaint could not be confirmed as the broken anchor was not returned.No abnormality found on the returned driver.The most likely cause(s) of this event include not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is still loaded.
Additional Manufacturer Narrative
This is a duplicate follow-up.The complaint could not be confirmed as the broken anchor was not returned.No abnormality found on the returned driver.The most likely cause(s) of this event include not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is still loaded.

• Brand Name: SUTURE ANCHOR, BIO-PUSHLOCK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8174778
• Report Number: 1220246-2018-00808
• Device Sequence Number: 19207858
• Product Code: MAI
• UDI-Device Identifier: 00888867023000
• UDI-Public: 00888867023000
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2020

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: No Information
• Device Expiration Date: 01/31/2020
• Device Model Number: SUTURE ANCHOR, BIO-PUSHLOCK
• Device Catalogue Number: AR-1923B-1
• Device Lot Number: 10192884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 11/30/2018; 11/30/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/17/2019; 03/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other