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

Catalog Number 72203793

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/03/2018

Event Type  malfunction  

Event Description

It was reported that the tip of the needle breaks at the weakening spot where the suture is supposed to pass through and the broken pieces are unable to be remove from the patient's anatomy.The broken tip gets into the soft tissue.The needle was passed at least one time through the cuff, when is passed the second or third time it breaks.No patient injury reported.Back up device was available.

Manufacturer Narrative

One truepass needle was returned for evaluation.Visual examination of the needle confirmed the reported complaint.The needle tip has broken off at the suture slot.Broken tip was not returned.The retained needle tip is considered to be bio compatible.However, it is unknown if corrosion, micro-motion and/or migration of the retained needle tip is possible.Although it was reported that the procedure was completed with no harm to the patient, the patient¿s post-operative condition is unknown at this time and future patient impact cannot be determined.

• 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 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8005184
• MDR Text Key: 125128749
• Report Number: 1219602-2018-01447
• Device Sequence Number: 0
• Product Code: NBH
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2023
• Device Catalogue Number: 72203793
• Device Lot Number: 50708912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2018
• 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