MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR BLADE,4.5(6BX); SAW, POWERED, AND ACCESSORIES

Catalog Number 7205332

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 10/29/2015

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: foreign postal code: and foreign phone number: (b)(6).Visual examination of the device confirmed the reported breakage.The outer and inner blade tips have broken off.The outer tip has broken off at the weldment.Examination of the weldment confirmed it did not meet print specification.After the evaluation the root cause for the reported issue could not be determined.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that during a knee scope procedure, the healthcare professional was using the shaver blade when the tip of the blade at the curve became dislodged and broke off inside the joint.The tip was removed from the joint space with graspers.A backup was available to complete the procedure successfully.There were no reported patient injuries.No other complications were noted.

• Brand Name: BOXED INCISOR BLADE,4.5(6BX)
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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: 5970496
• MDR Text Key: 55680163
• Report Number: 1219602-2016-00860
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/29/2015

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 Expiration Date: 02/06/2019
• Device Catalogue Number: 7205332
• Device Lot Number: 50792798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1