MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL 4.5MM, DSPL., EP-1; SAW, POWERED, AND ACCESSORIES

Model Number 7205306

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

During a shoulder scope procedure (date unknown), using a full radius bl 4.5mm, dspl., ep-1, it was reported that the blade shed into the joint.The surgeon removed most of the debris, but was unable to remove all of the pieces.There were no reports of patient injuries or complications.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.(b)(4).

Manufacturer Narrative

Evaluation of the device was not possible, as the device is not being returned.Review of the device history records were performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.Due to this fact we are unable to determine what may have caused the user to experience the reported incident.No further investigation is warranted at this time.

• Brand Name: FULL RADIUS BL 4.5MM, DSPL., EP-1
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491462
• MDR Report Key: 4765990
• MDR Text Key: 5953244
• Report Number: 1219602-2015-00101
• Device Sequence Number: 1
• Product Code: HAB
• 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,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• 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 Model Number: 7205306
• Device Catalogue Number: 7205306
• Device Lot Number: 50776190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2015
• Date Device Manufactured: 11/25/2013
• 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