MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPRESSION SCREW DRIVER GUIDE, 20MM; BIT, DRILL

Model Number	BIO-COMPRESSION SCREW DRIVER GUIDE, 20MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
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 that during a procedure, when the surgeon was drilling to the positive stop, when the stop was reached, the guide internally shattered and broke into two pieces.All pieces were retrieved and the case was completed by using a new ar-5025g.
Additional Manufacturer Narrative
Complaint confirmed, the device broke in two pieces at the interface between the shaft and knurled component.The shaft was not returned.Cracks can be see inside the clear device returned.The cause of the event is undetermined, however a likely cause is user-applied mechanical forces.

• Brand Name: BIO-COMPRESSION SCREW DRIVER GUIDE, 20MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12032276
• Report Number: 1220246-2021-03285
• Device Sequence Number: 3800382
• Product Code: HTW
• UDI-Device Identifier: 00888867034822
• UDI-Public: 00888867034822
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/07/2021

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: BIO-COMPRESSION SCREW DRIVER GUIDE, 20MM
• Device Catalogue Number: AR-5025G
• Device Lot Number: 011931
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 07/07/2021
• Patient Sequence Number: 1