MAUDE Adverse Event Report: ARTHREX, INC. CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2020
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 ankle arthroscopy an ar-8655-06 (lot 1391935) (from set ar-8655s) was being used.The tip of the chondral pick broke off.All pieces of the device were fully retrieved.In order to finish the procedure the surgeon discontinued the arthroscopy and transition to an open procedure.Additional information obtained 10/9/20: there was no other 60 degree pick available to use.The initial microfracture location was performed without incident.The pick broke upon setting by hand the position for the second location of microfracture.Bone quality was reported to be normal.The open procedure was part of the original surgical plan.However, the anteromedial portal did need to be extended about one cm as the broken piece of the chondral pick was retained within soft tissue upon the surgeon's initial attempt to remove it arthroscopically.
Additional Manufacturer Narrative
Complaint confirmed, the tip was found to have broken off near the bend.Review of the dhr shows the device met material specifications.A likely cause of the event is prying/leveraging the device during use.

• Brand Name: CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10730445
• Report Number: 1220246-2020-02252
• Device Sequence Number: 17008650
• Product Code: LXH
• UDI-Device Identifier: 00888867044296
• UDI-Public: 00888867044296
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
• Device Catalogue Number: AR-8655-06
• Device Lot Number: 1391935
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 10/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other