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

Model Number	SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/24/2019
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 devices were reported to have been discarded at the facility.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 during a slap repair procedure, a quantity three ar-1926bc suture anchor bio-composite pushlocks lot: 10322845 malfunctioned.The bone tunnel was drilled using ar-1912 (drill for 3.5 mm pushlock) and ar-1909r (offset guide for 3.5 mm pushlock).The drill was cycled 4-5 times each time, and the anchor was inserted at the same angle of drilling.While the anchors were being inserted, the leading edge of the pushlocks began to split in half and exit out of the bone tunnel leaving only half of the anchor in the bone tunnel for fixation.The portion of the anchor that curled out of the bone tunnel was retrieved with graspers and disposed of.The remaining portions of the three anchors that stayed in the bone tunnel were secured, and left implanted.The bone quality was normal, and was not abnormally hard or soft.It was reported that a second surgery is not needed.The rep reported there was no additional or unplanned incisions / portals made.The implants were being placed into the glenoid rim for slap repair.Once the anchor was fully seated, the pushlock handle was twisted and removed, the anchor portion that exited the bone tunnel was retrieved from the patient and disposed of and the fiberwire suture was cut flush with the anchor, leaving a portion of the anchor in the tunnel for fixation.There were no implants placed over the portions of the broken implants in the tunnels.

• Brand Name: SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9396540
• Report Number: 1220246-2019-01446
• Device Sequence Number: 2167038
• Product Code: MAI
• UDI-Device Identifier: 00888867023239
• UDI-Public: 00888867023239
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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: 05/31/2021
• Device Model Number: SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
• Device Catalogue Number: AR-1926BC
• Device Lot Number: 10322845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/02/2019
• 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