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

Catalog Number 7209499

Device Problems Bent (1059); Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/16/2017

Event Type  malfunction  

Event Description

It was reported the arthropierce was bent.It was examined prior to the case and was not bent.It is noted in sap as being broken in the patient and removed from the patient.

Manufacturer Narrative

Other: no evaluation conducted to date due to no product being available for return.Examination was not possible, as the device has not been returned.The investigation was limited to the information provided; the investigation could not draw any conclusions about the reported event without the return of the device in question.Further investigation is not warranted at this time.

• Brand Name: ARTHROPIERCE 35 DEGREE UP
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon; austin, TX 78735
• MDR Report Key: 6722923
• MDR Text Key: 80429813
• Report Number: 1219602-2017-00764
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

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 Catalogue Number: 7209499
• Device Lot Number: 50544110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 07/18/2017
• Supplement Dates Manufacturer Received: 06/20/2017
• Supplement Dates FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1