MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA PAC, 1.2; ARTHROSCOPE

Catalog Number 72202799

Device Problem Break (1069)

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

Event Date 12/31/2015

Event Type  malfunction  

Manufacturer Narrative

A visual inspection of the device confirmed the reported breakage.Approximately 1.5¿ of the guide wires tip has broken off.An examination of the tip shows a small portion of the drill tip is missing and was not returned for evaluation.The tip is heavily scored and appears to have been bisected during over-drilling.The shaft is slightly bent and scored in several locations along its length.Dimensional inspection was limited to its major diameter due to its condition, the device met print specification.The observed damage is consistent with drilling over a bent guide wire.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the 2.4 guide pin broke while reaming the tibial tunnel.No patient injury or other complications were reported.

• Brand Name: ENDOBUTTON CL ULTRA PAC, 1.2
• Type of Device: ARTHROSCOPE
• 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: 5973067
• MDR Text Key: 55733718
• Report Number: 1219602-2016-00933
• Device Sequence Number: 1
• Product Code: HRX
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 72202799
• Device Lot Number: 50571417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1