MAUDE Adverse Event Report: ARTHREX, INC. ELEVATOR, ANKLE ARTHRO SCOPY, SHARP; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	ELEVATOR, ANKLE ARTHRO SCOPY, SHARP
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/18/2019
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 microfracture/debridement of ocd; brostrum-goulde procedure the ar-8655-13 was used to debride ocd and the ar-8655-12 elevator ankle arthroscopy sharp tip broke off with minimal application / force.The rep stated the procedure started arthroscopic and turned open to retrieve the broken fragment.Three incisions were used.The tip migrated posteriorly where it was fully retrieved, and the case was completed.The device and retrieved broken fragment are available to return for evaluation.
Additional Manufacturer Narrative
Complaint confirmed, the hook tip was found to have broken off from the device.The most likely cause is prying and/or leveraging the device during use.

• Brand Name: ELEVATOR, ANKLE ARTHRO SCOPY, SHARP
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9443623
• Report Number: 1220246-2019-01466
• Device Sequence Number: 11322104
• Product Code: MDM
• UDI-Device Identifier: 00888867044340
• UDI-Public: 00888867044340
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: ELEVATOR, ANKLE ARTHRO SCOPY, SHARP
• Device Catalogue Number: AR-8655-12
• Device Lot Number: 1391810
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other