MAUDE Adverse Event Report: ARTHREX, INC. IB KIT, PEEK, NON-COLLAGEN COATED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IB KIT, PEEK, NON-COLLAGEN COATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
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 internalbrace ligament reconstruction surgery a drill bit of the ar-1778p-cp kit broke off inside the patient.The broken pieces were retrieved from patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged kit, ar-1778p-cp batch 15147539, was received for evaluation.Upon visual inspection, it was noted that the 3.4 mm drill bit flute was chipped and broken off.It was also noted that the guidewire was cut with many scratches around the outside diameter.This is likely caused by interference from another instrument.Evaluation of the returned device included overall length measurements per drawing c16909 at revision 6.Overall length 4.500.030 in.The device measured 4.409 in.The device's length is shorter due to the break.The most likely cause(s) for the reported failure can be a user error, misaligned insertion, or interference with another instrument.

• Brand Name: IB KIT, PEEK, NON-COLLAGEN COATED
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18564741
• Report Number: 1220246-2024-00482
• Device Sequence Number: 20498163
• Product Code: MAI
• UDI-Device Identifier: 00888867318120
• UDI-Public: 00888867318120
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K101823
• 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): 07/10/2024

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: IB KIT, PEEK, NON-COLLAGEN COATED
• Device Catalogue Number: AR-1778P-CP
• Device Lot Number: 15147539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown