MAUDE Adverse Event Report: ARTHREX, INC. CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2020
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 the ar-8655-06 chondral pick was inserted into the ankle joint for an ocd lesion case.Per the rep present, the surgeon had applied slight pressure to the pick prior to malleting and the tip broke off into the joint.The surgeon tried to retrieve it with a grasper, but it migrated to the back of the ankle.They took an x-ray to locate it and then 4 additional incisions were needed to retrieve the tip from the posterior of the tibula.The case was then completed.Patient is female, (b)(6) years.

• Brand Name: CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEG
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10634206
• Report Number: 1220246-2020-02216
• Device Sequence Number: 2727958
• Product Code: LXH
• UDI-Device Identifier: 00888867044296
• UDI-Public: 00888867044296
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/06/2020

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR