MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE 35 DEGREE UP; ACCESSORIES,ARTHROSCOPIC

Model Number	7209499
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke during a case.The device broke off in the patient and the piece was removed.Procedure completed with a competitor device.A delay of 45 minutes was reported.
Additional Manufacturer Narrative
One 7209499 arthropierce 35 degree up angled instrument was reported on indicating instrument breakage.The device was not returned for evaluation.Physical conclusions, full investigation and evaluation were not possible.Factors affecting device performance include: device ability, surgical ability and surgical site preparation.These instruments are designed for repeated use with proper care and handling.Instrument tips may inadvertently be twisted or caught on other instruments or the basket during cleaning.This can lead to compromised strength.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in the instrument's failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.Final product met predetermined specifications upon release to distribution.

• Brand Name: ARTHROPIERCE 35 DEGREE UP
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7936281
• Report Number: 1219602-2018-01381
• Device Sequence Number: 931051
• Product Code: NBH
• UDI-Device Identifier: 03596010474544
• UDI-Public: (01)03596010474544(10)50591607
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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: 7209499
• Device Catalogue Number: 7209499
• Device Lot Number: 50591607
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1