MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPRESSION SCREW 3 X 18MM; SCREW, FIXATION, BONE

Model Number	BIO-COMPRESSION SCREW 3 X 18MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/11/2022
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 an ocd repair surgery the bio-compression screws broke while inserting.The first one broke about 4mm to complete the insertion.The second one broke with half of the screw outside the bone.The tunnel was drilled with the correct drill size and tap.Apparently the screw was being introduced in the correct direction.The broken part remains in patient.The surgery was finished successfully with chondral darts ar-4005b-18.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: BIO-COMPRESSION SCREW 3 X 18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14269636
• Report Number: 1220246-2022-04819
• Device Sequence Number: 5158857
• Product Code: HWC
• UDI-Device Identifier: 00888867034693
• UDI-Public: 00888867034693
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K060478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

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 Expiration Date: 08/31/2023
• Device Model Number: BIO-COMPRESSION SCREW 3 X 18MM
• Device Catalogue Number: AR-5025B-18
• Device Lot Number: 14231004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/03/2022
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown