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

Catalog Number 72203793

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6) (b)(4).

Event Description

It was reported that the ends of 2 truepass needles broke off inside the tendon tissue of a patient while attempting to pass a suture for a rotator cuff repair.The two pieces that had broken off were not able to be retrieved but were confirmed by x-ray to still be in the joint.A back-up device was available and the procedure was completed successfully.No follow-up report on patient condition is available.

Manufacturer Narrative

Device investigation narrative - two used and five unopened truepass needles were returned for evaluation.Visual examination of the used needles confirmed the reported complaint.The needle tips have broken off at the suture slot.Broken tips were not returned for examination.The needles are also scored proximal to the break.Two of the unused devices were opened and dimensionally inspected, both needles were found to meet print specifications.A root cause investigation has been opened to address this failure mode.(b)(4).

• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5454129
• MDR Text Key: 38791654
• Report Number: 1219602-2016-00102
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 72203793
• Device Lot Number: 50496563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 02/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2014
• 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