MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE 35 DEGREE UP; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7209499

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

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

Event Date 10/31/2014

Event Type  malfunction  

Manufacturer Narrative

One 35 degree up arthropierce was returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.Shaft is broken where it interfaces with the handle.Shaft is dramatically bent.Movable jaw is missing and was not returned for evaluation.The condition of the device is the direct result of excessive force placed on it during use.

Event Description

Broken shaft tried to pass a suture, and the shaft from the instrument broke.Device fell off into the patient; it was able to be removed.No other complications were noted.

• Brand Name: ARTHROPIERCE 35 DEGREE UP
• 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: 5955790
• MDR Text Key: 54929924
• Report Number: 1219602-2016-00622
• Device Sequence Number: 1
• Product Code: NBH
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/31/2014

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: No Information
• Device Catalogue Number: 7209499
• Device Lot Number: T2408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1