MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI,30MM LGTH; PLATE, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI,30MM LGTH
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2021
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
It was reported during a procedure on (b)(6) 2020 the tip of a ar-8737-37 (lot: 1391933) broke off in the head of the ar-8730-30h (lot: 10668937) screw.When the breakage occurred, the screw was unable to be fully seated and was left proud.The surgeon removed the screw on (b)(6) 2021 using another manufacturer's removal system.The rep reported there were no arthrex products implanted during the revision surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8730-30h screw (no batch indicator provided) was received for investigation.Visual inspection using micro-vu id: 654 identified that the tip of a driver was indeed lodged within the hex of the returned ar-8730-30h.Due to the location of the driver fragment, as well as the warped condition of the hex, the dimensions of the screw hex could not be accurately measured.The threading surrounding the hex was severely stripped and warped.Material analysis testing identified that the screw met design specifications for the material composition.The root cause of the event remains undetermined.However, the most probable cause can be linked to over-engaging the driver within the screw head, alongside the application of excessive force during insertion.

• Brand Name: COMPR FT SCRW,3.5 MINI,30MM LGTH
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11871768
• Report Number: 1220246-2021-03129
• Device Sequence Number: 13705503
• Product Code: HRS
• UDI-Device Identifier: 00888867127043
• UDI-Public: 00888867127043
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: COMPR FT SCRW,3.5 MINI,30MM LGTH
• Device Catalogue Number: AR-8730-30H
• Device Lot Number: 10668937
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other