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

Model Number	72201186
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10483381
• Report Number: 1219602-2020-01348
• Device Sequence Number: 19681918
• Product Code: NBH
• UDI-Device Identifier: 03596010605610
• UDI-Public: 03596010605610
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1