MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO,SCOOP, STRAIGHT, PROLINE, 1.7MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72202005

Device Problems Break (1069); Component Falling (1105)

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

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

A visual inspection of the device confirmed the reported complaint of breakage.The actuators distal end that interfaces with the upper jaw has broken.The broken piece was not returned.A dimensional assessment of the remaining portion of the device found it met print specifications.Without the return of the missing portion of the actuator, a root cause for this failure cannot be determined.No root cause related to the manufacture of the device can be established.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

The surgeon was using the acufex 1.7 mm scoop as usual in a patient's knee to remove a piece of the meniscus.The scoop scissors piece broke and fell off the acufex.The piece was retrieved from the patient.No patient injury or other complications were reported.

• Brand Name: MTO,SCOOP, STRAIGHT, PROLINE, 1.7MM
• 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: 5971740
• MDR Text Key: 55680169
• Report Number: 1219602-2016-00899
• 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: 06/24/2015

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: Other
• Device Catalogue Number: 72202005
• Device Lot Number: 50261001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1