MAUDE Adverse Event Report: ARTHREX, INC. FLX REAMER & TIGHTROPE DRILL PIN 9.0MM; BIT, SURGICAL

Model Number FLX REAMER & TIGHTROPE DRILL PIN 9.0MM

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

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.

Event Description

It was reported that the ar-1401f-90 flexible reamer broke as the surgeon was drilling the femur.The broken reamer was removed and the case was completed by using another reamer.

Manufacturer Narrative

- it was reported that the reamer broke during the procedure.- visual evaluation identified that the flexible reamer had fractured off of the drill.However, without the return of the device, further investigation cannot be performed.Additionally, patient bone quality and surgical technique were not reported.- the root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.- the reported event is confirmed based on the investigation of the returned pictures.

• Brand Name: FLX REAMER & TIGHTROPE DRILL PIN 9.0MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11648510
• MDR Text Key: 247321713
• Report Number: 1220246-2021-02887
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

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
• Device Operator: Health Professional
• Device Model Number: FLX REAMER & TIGHTROPE DRILL PIN 9.0MM
• Device Catalogue Number: AR-1401F-90
• Device Lot Number: 18E64
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 09/07/2021
• Patient Sequence Number: 1