MAUDE Adverse Event Report: ARTHREX, INC. DRV,3.5MM HEX,CANN (MINI HUDSON); FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	DRV,3.5MM HEX,CANN (MINI HUDSON)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
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
On 09/07/2021, it was reported by a sales representative via e-mail that the ar-8967d drive tip broke while inserting a screw.This was discovered during use in a procedure on (b)(6) 2021.The case was completed with a new ar-8967d.Additional information provided 09/08/2021: the tip of device broke off completely.The fragment was removed from the patient and the case was completed by using a new ar-8967d.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8967d, batch 47322007 was received for investigation.Visual inspection identified that the drive geometry had broken.The fragment detailed in the event description was not returned for analysis.Due to the severity of the damage present, no accurate measurements could be assessed of the distal tip.The cause remains undetermined, although a probable cause can be attributed to user applied mechanical forces during use.

• Brand Name: DRV,3.5MM HEX,CANN (MINI HUDSON)
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12540085
• Report Number: 1220246-2021-03698
• Device Sequence Number: 19729333
• Product Code: LXH
• UDI-Device Identifier: 00888867056718
• UDI-Public: 00888867056718
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRV,3.5MM HEX,CANN (MINI HUDSON)
• Device Catalogue Number: AR-8967D
• Device Lot Number: 47322007
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/20/2021
• Patient Sequence Number: 1