MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ELITE PASS SUTURE SHUTTLE WITH RATCHET; ACCESSORIES, ARTHROSCOPIC

Catalog Number 7211020

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/05/2017

Event Type  malfunction  

Event Description

It was reported that when trying to push the elite pass suture shuttle, the top of the mouth broke off and was loose in the joint.

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.

• Brand Name: ELITE PASS SUTURE SHUTTLE WITH RATCHET
• 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: 6278871
• MDR Text Key: 66037812
• Report Number: 1219602-2017-00110
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

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: Health Professional
• Device Catalogue Number: 7211020
• Device Lot Number: LT1307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1