MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT FOR 2.9MM PUSHLOCK; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	DISPOSABLE KIT FOR 2.9MM PUSHLOCK
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	10/04/2019
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 bankart procedure, as the surgeon was using the ar-1923ds disposable kit for 2.9 mm pushlock to drill for the second pushlock, the drill welded to the drill guide.When the surgeon tried to separate the two, the drill heated up so much that it melted the handle, and slid down the shaft of the guide.The surgical assistant grabbed the drill, and the drill ended up burning their hand.A second drill guide was not available.A 2.5 guide wire was used to create a hole for the insertion of the pushlock.Two additional pushlocks were implanted using this method.The rep reported the procedure was completed and the patient outcome was good.Additional information has been requested.Additional information received on 10/08/2019: the rep stated that the burn was minor, and there are no available pictures of the burn.The doctor ran the burn under cold water.The rep reported the drill did not come into contact with the patient, and no other individual was burned.No additional incisions were necessary.The device will be returning for evaluation.
Additional Manufacturer Narrative
Complaint confirmed, the drill bit was found to be stuck inside the shaft/sleeve.The shaft was found to have pulled out from the handle.The most likely cause of the drill bit being stuck in the shaft is bending the device during use.The shaft most likely pulled out due to the heat generated by the drill bit, when the user attempted to pull the drill bit out.

• Brand Name: DISPOSABLE KIT FOR 2.9MM PUSHLOCK
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9225969
• Report Number: 1220246-2019-01376
• Device Sequence Number: 2483792
• Product Code: MDM
• UDI-Device Identifier: 00888867023079
• UDI-Public: 00888867023079
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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: 03/31/2024
• Device Model Number: DISPOSABLE KIT FOR 2.9MM PUSHLOCK
• Device Catalogue Number: AR-1923DS
• Device Lot Number: 10299798
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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