MAUDE Adverse Event Report: ARTHREX, INC. BB-TAK, THREADED, STRL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	BB-TAK, THREADED, STRL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2022
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 on (b)(6) 2022 by a facility representative via sems that an ar-13226ts bb-tak broke.This was discovered during a case and broke inside the patient.Per facility: "it was used to fix the fibula plate.The area between the head and shaft was broken off.".
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the device was broken between the head and the shaft of the device.The cause of this remains undetermined, however, probable cause can be attributed to prying/leveraging forces being used.

• Brand Name: BB-TAK, THREADED, STRL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 14744816
• Report Number: 1220246-2022-05123
• Device Sequence Number: 4677610
• Product Code: LXH
• UDI-Device Identifier: 00888867198609
• UDI-Public: 00888867198609
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 08/31/2022

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: 08/31/2026
• Device Model Number: BB-TAK, THREADED, STRL
• Device Catalogue Number: AR-13226TS
• Device Lot Number: 1231114947
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown