MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH,BSKT,DCKBL,STR,1.5MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number 012013

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

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

Event Date 01/07/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A visual examination of the device could not confirm any missing pieces.The device was disassembled for closer examination with the use of a stereo microscope.No pieces were observed to be missing.There is no evidence of any burrs that could have dislodged from the device as all edges have been broken per print specification.Due to these observations no root cause related to the manufacturing process can be established.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

The tip broke during the shoulder procedure.A small metal part of the instrument broke off in the patient.The piece was removed with the aid of suction.A back-up device was available for use.No patient injury or other complications were reported.

• Brand Name: PCH,BSKT,DCKBL,STR,1.5MM
• 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: 5963622
• MDR Text Key: 55471675
• Report Number: 1219602-2016-00717
• 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: 01/08/2014

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: 012013
• Device Lot Number: 50322392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1