MAUDE Adverse Event Report: ARTHREX, INC. GUIDE SLEEVE, DOUBLE BORE DIAM 1.6MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	GUIDE SLEEVE, DOUBLE BORE DIAM 1.6MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
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 that during an arthroscopic tfcc repair the arthrex devices ar-8816g-02 an ar-8816g were used.The sleeve does not lock into the target device.It's slipping and it's unstable.The patient was already under anesthesia.The surgeon had to cancel the surgery as he had no backup equipment.The second surgery took place on the 17th of december.No further information received.
Additional Manufacturer Narrative
Complaint not confirmed, even though the device did not lock with the returned ar-8816g, it was found to meet dimensional specifications and to lock with a new ar-8816g from inventory.

• Brand Name: GUIDE SLEEVE, DOUBLE BORE DIAM 1.6MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9568981
• Report Number: 1220246-2020-01554
• Device Sequence Number: 13576197
• Product Code: MDM
• UDI-Device Identifier: 00888867259928
• UDI-Public: 00888867259928
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: GUIDE SLEEVE, DOUBLE BORE DIAM 1.6MM
• Device Catalogue Number: AR-8816G-02
• Device Lot Number: 1448174701
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other