MAUDE Adverse Event Report: ARTHREX, INC. FIBERWIRE GRASPER W/ SR HANDLE; ACCESSORIES, ARTHROSCOPIC

Model Number FIBERWIRE GRASPER W/ SR HANDLE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, it was reported by a sales representative via sems that a ar-13975sr fiberwire® grasper w/sr handle is broken at the distal end of the tip.This occurred during a case, no pieces were left in the patient, and the case was completed.There was no patient effect reported.

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.

Manufacturer Narrative

Since the complaint device was not returned, a physical evaluation of the device was not performed.However, without the device being returned or any photos provided, the report event is not confirmed.Based on the device damage that was reported, the most likely cause for the reported failure can be attributed to misuse/mishandling.

Event Description

Additional information was provided on 12/16/2022 where it was reported that this event occurred on (b)(6) 2022 during an alc repair.The device bent while removing the hardware.Another grasper was used to complete the case.

• Brand Name: FIBERWIRE GRASPER W/ SR HANDLE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 16051575
• MDR Text Key: 308197397
• Report Number: 1220246-2022-05980
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/27/2022

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
• Device Operator: Health Professional
• Device Model Number: FIBERWIRE GRASPER W/ SR HANDLE
• Device Catalogue Number: AR-13975SR
• Device Lot Number: 14999540
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/27/2022
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1