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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was bent while using it.No patient injuries were reported.No backup was available from smith and nephew.
Additional Manufacturer Narrative
One arthropierce 35 degree up was returned for evaluation.Visual assessment confirmed the reported complaint.The distal tip is bent and twisted.The condition of the device indicates excessive force was placed on the tip during use resulting in its breakage.Per the device ifu under precautions "as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure." no root cause related to the manufacture of the device can be established.Correction in : company representative should be in blank.

• 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: 7906751
• Report Number: 1219602-2018-01326
• Device Sequence Number: 19228917
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1