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

Catalog Number 72202799

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

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

Event Date 12/17/2013

Event Type  malfunction  

Manufacturer Narrative

The reported device was not returned for evaluation.A picture of the device was examined, and the reported complaint was confirmed, as the acorn head of the reamer was not attached to the end of the device.A functional test was not possible.A review of the device history records was performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.A complaint history review has not identified additional complaints for this lot number on file.The root cause was not able to be determined without the device being returned.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 the tip of the drill broke off during use.The broken piece was removed from the surgical site and the procedure was successfully completed using a back-up device.No patient injury or other complications were reported.

• Brand Name: ENDOBUTTON CL ULTRA PAC, 1.2
• Type of Device: PASSER
• 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: 5966930
• MDR Text Key: 55272130
• Report Number: 1219602-2016-00785
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 72202799
• Device Lot Number: 50482301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2014
• Date Device Manufactured: 11/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1