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	No Code Available (3191)
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 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 total of six ar-1926bc suture anchor bio-composite pushlocks (lot: 10316272 / qty.3 and lot: 10322845 / qty.3) malfunctioned.The bone tunnel was drilled using ar-1912 (drill for 3.5mm pushlock) and ar-1909r (offset guide for 3.5mm pushlock).The drill was cycled 4-5 times each time, and the anchor was inserted at the same angle of drilling.Five out of the six ar-1926bc broke upon insertion.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 five anchors that stayed in the bone tunnel were secured, and left implanted.The sixth ar-1926bc (lot: 10316272) split before being impacted with the mallet, upon the anchor becoming flush with the bone.This anchor was fully removed, and will be returning for evaluation (see attached image of device).The bone quality was normal, and was not abnormally hard or soft.It was reported that a second surgery is not needed.Additional information received on 11/14/2019: the rep reported the original report of total of six ar-1926bc suture anchor bio-composite pushlocks (lot: 10316272 / qty.3 and lot: 10322845 / qty.3) malfunctioning actually occurred in two separate procedures on two different patients.Three ar-1926bc (lot: 10316272) malfunctioned in one procedure, and three ar-1926bc (lot: 10322845) malfunctioned in the second procedure.Case 33266-1 has been created to record the second procedure.Both procedures were slap repairs that took place on the same day, and were performed by the same surgeon.The rep reported there was no additional or unplanned incisions/portals made.The implants were being placed into the glenoid rim for slap repair.The rep reported during each procedure 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.Case 32520-1: ar-1926bc (lot: 10316272 / qty.3).Case 33266-1: ar-1926bc (lot: 10322845 / qty.3).This medwatch report (1220246-2019-01425) is for case (b)(4).Case (b)(4) will be reported under a separate medwatch report.

• 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: 9353290
• Report Number: 1220246-2019-01425
• Device Sequence Number: 14005194
• 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: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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: 04/30/2021
• Device Model Number: SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
• Device Catalogue Number: AR-1926BC
• Device Lot Number: 10316272
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/21/2019
• 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