MAUDE Adverse Event Report: ARTHREX, INC. BTB IB TIGHTROPE W FLIPCUTTER III DRILL; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	BTB IB TIGHTROPE W FLIPCUTTER III DRILL
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 it was reported by a sales representative via the phone that the blade of an ar-1204ff flipcutter, from the ar-1288btbib-fc3 tightrope kit, broke off into 2 pieces as the surgeon was drilling.All fragments were removed using a grasper.This was discovered during use in an acl procedure.The case was completed by opening a single ar-1204ff.
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.
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) 2021 it was reported by a sales representative via the phone that the blade of an ar-1204ff flipcutter, from the ar-1288btbib-fc3 tightrope kit, broke off into 2 pieces as the surgeon was drilling.All fragments were removed using a grasper.This was discovered during use in an acl procedure.The case was completed by opening a single ar-1204ff.

• Brand Name: BTB IB TIGHTROPE W FLIPCUTTER III DRILL
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: 12953879
• Report Number: 1220246-2021-04063
• Device Sequence Number: 4390165
• Product Code: MBI
• UDI-Device Identifier: 00888867379961
• UDI-Public: 00888867379961
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K202581
• 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): 12/07/2021

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: BTB IB TIGHTROPE W FLIPCUTTER III DRILL
• Device Catalogue Number: AR-1288BTBIB-FC3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown