MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCHBIO-COMP S-TAK KNOTLESS; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCHBIO-COMP S-TAK KNOTLESS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/06/2020
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
It was reported that while performing a (b)(6) 2020 inferior anterior and posterior labral repair of a left shoulder, the surgeon decided to use a knotless fibertak (ar-3638) to access the 5 o'clock position (low anterior) of the glenoid.A knotless fibertak had already been placed at the inferior-most aspect of the glenoid.The drill guide (ar-3638dc) was placed through the anterior portal onto the low anterior glenoid rim.The drill guide was gently tapped with a mallet to seat it on the rim.The appropriate knotless fibertak drill bit was inserted into the drill guide and drilled into the glenoid.The surgeon observed that the bone felt "very hard" as the drill was being advanced.The drilling was completed and the drill was removed.The anchor was then inserted down the drill guide and malleted into the socket.When the knotless fibertak inserter was gently tugged on to set the anchor, the anchor explanted from the socket in its entirety.A knotless suturetak (ar-1938bc) was used adjacent to the knotless fibertak position, just slightly superior.No concerns were noted or addressed at the time of surgery.Two week post operative x-ray images showed a metallic object in the low anterior glenoid in the relative position where the initial knotless fibertak had explanted from.Approximately 5mm of some metallic object was retained in the low anterior glenoid of the patient's left shoulder.Neither the surgeon nor supporting technology consultant are sure what item is retained; whether it is part of the anchor inserter or the flexible drill bit.Additional information obtained 10/21/20: the drill guide was intact.It is unknown if the inserter device was checked after the procedure.The drill bit was not checked after the procedure.All drill bits and inserters were discarded at the time of use.There are no plans for a second procedure unless the retained items causes problem in the future.

• Brand Name: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10785920
• Report Number: 1220246-2020-02311
• Device Sequence Number: 2938266
• Product Code: MAI
• UDI-Device Identifier: 00888867097186
• UDI-Public: 00888867097186
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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 Model Number: SUTR ANCHBIO-COMP S-TAK KNOTLESS
• Device Catalogue Number: AR-1938BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other