MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-FIX RCG STERILE PAC; ARTHROSCOPE

Catalog Number 014771

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It is reported that after an arthroscopic procedure the surgeon x-rayed the patient and saw that a part of the glenoid drill had broken off and been left in the glenoid.Patient was made aware of this and no further action has been taken.

Manufacturer Narrative

Device investigation 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.No further investigation is warranted at this time.(b)(4).

• Brand Name: T-FIX RCG STERILE PAC
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5539776
• MDR Text Key: 41648161
• Report Number: 1219602-2016-00174
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K925573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 014771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention