MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE INSTRUMENT CURVED LEFT; ACCESSORIES,ARTHROSCOPIC

Model Number 72201186

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2020

Event Type  malfunction  

Event Description

It was reported that during a shoulder arthroscopy procedure, the arthro-pierce instrument curved left broke.However, there was no breakage inside the patient.Backup device was available to complete the procedure.However, no delay and no patient complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 72201186 arthropierce instrument curved left was returned for evaluation.The information provided states: ¿during a shoulder arthroscopy procedure, the arthro-pierce instrument curved left broke¿.Visual assessment confirms complaint.The tip of the arthropierce showed breakge.There was a relationship between the reported even and the device.An exact root cause cannot be determined with confidence factors that could have contributed to the reported event include: excessive force or improper cleaning of device.Ifu (1060355) states: ¿pay careful attention to cleaning devices with challenging design features.Challenging design features can include, but not limited to, suction levers, stopcocks, interfaces, cannulations, holes, blind holes, crevices, hinges, mating surfaces, etc¿.

• Brand Name: ARTHROPIERCE INSTRUMENT CURVED LEFT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10483381
• MDR Text Key: 207220078
• Report Number: 1219602-2020-01348
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010605610
• UDI-Public: 03596010605610
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

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: 72201186
• Device Catalogue Number: 72201186
• Device Lot Number: 50807924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1