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

Catalog Number 72201187

Device Problems Bent (1059); Break (1069); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was visually inspected and the reported failure mode was confirmed.The device was observed to be broken at the tip, and the actuator knob is damaged.The device manufacturing record was reviewed, and no issues were identified with the manufacture of the device.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

While performing a surgery the tip broke, it became stuck within the guide, bent, and broke.The problem occurred when the surgeon was recovering the first stitch, the suture got stuck in the tip; the problem was resolved without forcing the device.No patient injury or other complications were reported.

• Brand Name: ARTHROPIERCE INSTRUMENT, CURVED RIGHT
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5965076
• MDR Text Key: 55445723
• Report Number: 1219602-2016-00758
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 72201187
• Device Lot Number: 50495464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1