MAUDE Adverse Event Report: ARTHREX, INC.; PIN, FIXATION, SMOOTH

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2021

Event Type  malfunction  

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 Description

On 11/01/2021, it was reported by a sales representative via e-mail that while the surgeon was using an ar-1204ff flipcutter and was cutting in the retrograde direction, the flipcutter stopped reaming.When the surgeon pulled back the device, the tip of the flipcutter broke inside of the patient.This was discovered during use in a revision quad tendon acl recon with fibertag tightrope rt on (b)(6) 2021.The metal fragment was retrieved and the case was completed by using a new ar-1204ff.Additional information provided 11/3/2021: the primary procedure took place 6 years ago.During this revision.An acl tightrope rt was explanted.Additional information provided 11/04/2021 per the sales representative the explanted device is unknow but he is assuming an ar-1588rt or a ar-1588rt-j.The only part explanted was (the small metal button).

Manufacturer Narrative

Complaint confirmed.Visual evaluation identified that the tip of the device had fractured off.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.

• Brand Name: UNK
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 12853318
• MDR Text Key: 281139869
• Report Number: 1220246-2021-03972
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other