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

Model Number	BB-TAK, SMALL
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/26/2022
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
On (b)(6) 2022, it was reported by a sales representative via sems that a ar-18700-34 bb-tak, and a ar-18700-89 drill bit broke.This occurred on (b)(6) 2022 during a cunieform fx when the surgeon was using a 1.6 cage plate out of the minifrag for a medial cunieform fx.She was drilling with the 1.2 drill bit with the variable angle guide and the drill bit broke off into the patient.She was able to retrieve the fragment.After that they switched to the short 1.2 drill bit and still used the variable angle guide.All was going well until drilling for the very last screw.The 1.2 short drill broke also.All fragments were retrieved, and the case was completed.No additional information provided.

• Brand Name: BB-TAK, SMALL
• 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: 15794062
• Report Number: 1220246-2022-05752
• Device Sequence Number: 5850635
• Product Code: LXH
• UDI-Device Identifier: 00888867312784
• UDI-Public: 00888867312784
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 11/14/2022

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 Model Number: BB-TAK, SMALL
• Device Catalogue Number: AR-18700-34
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown