MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE 45 DEG RIGHT; ACCESSORIES,ARTHROSCOPIC

Catalog Number	7209497
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the tip of the device was broken outside the patient and no delay or patient injuries were reported.The procedure was completed with the competitor device.
Additional Manufacturer Narrative
The reported arthropierce 45 degree right intended for use in treatment, was returned for evaluation.Visual assessment of the device confirmed the reported breakage.The fixed and movable jaw have been broken off the shaft and were not returned for examination.The shaft is bent and dramatically twisted.The condition of the device indicates it was subjected to excessive forces during use.Per the device instructions for use ¿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¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The reported arthropierce 45 degree right, intended for use in treatment, has not been returned for evaluation.It is difficult to perform an accurate evaluation of a failure without having the failed product or the pertinent clinical details to consider.From the information provided, the tip broke off.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.Was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ARTHROPIERCE 45 DEG RIGHT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8608152
• Report Number: 1219602-2019-00547
• Device Sequence Number: 1808241
• Product Code: NBH
• UDI-Device Identifier: 03596010474520
• UDI-Public: 03596010474520
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 10/29/2019

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 Catalogue Number: 7209497
• Device Lot Number: 50761891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 06/03/2019; 10/28/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/04/2019; 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1