MAUDE Adverse Event Report: ARTHREX, INC. MENISCAL ROOT MARKING HOOK; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	MENISCAL ROOT MARKING HOOK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported during a procedure , when the surgeon was drilling a pin through the guide, the pin did not hit the guide to stop the pin from advancing into any structures behind the guide.The guide was assembled correctly and there was the appropriate sized sheath in the guide.Surgeon advanced the pin in a slow precise manner.Surgeon abandoned procedure over safety concerns.Additional information: on 7/8/2021: per the sales rep, pin did not hit guide like intended.Which did not stop pin from advancing into structures behind guide.Couldn t visualize.The device will not be returned.

• Brand Name: MENISCAL ROOT MARKING HOOK
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12231896
• Report Number: 1220246-2021-03442
• Device Sequence Number: 3635846
• Product Code: MDM
• UDI-Device Identifier: 00888867241916
• UDI-Public: 00888867241916
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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: MENISCAL ROOT MARKING HOOK
• Device Catalogue Number: AR-1610MR
• Device Lot Number: 43211722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other