MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUEPASS NEEDLE SINGLE PACK STERILE BX 5; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72203793

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Component Missing (2306)

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

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a shoulder scope the truepass device fell on the floor.The device was cleaned and soaked.The surgeon attempted to use it again, but the needle had broke off.The surgeon looked inside of the joint and all around the area, but the tip was not found.The patient was sent to x-ray to verify if a piece was left in the patient.

Manufacturer Narrative

Examination was not possible, as the device will not be returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.

• Brand Name: TRUEPASS NEEDLE SINGLE PACK STERILE BX 5
• 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 ; 7000 w. william cannon; austin, TX 78735 ; 5123585706
• MDR Report Key: 6066195
• MDR Text Key: 59030270
• Report Number: 1219602-2016-01219
• 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,Followup
• Report Date: 12/27/2016

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: 72203793
• Device Lot Number: 50608680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1