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

Catalog Number 72203793

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the distal tip of the needle, approx.1-2 mm broke off and one of the two tips that did break couldn't not be located and removed from the patient.

Manufacturer Narrative

One truepass suture shuttle needle was returned for evaluation.Visual examination of the needle confirmed the reported complaint.The needle tip has broken off at the suture slot.The broken tip was not returned.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force on the needle during use, inadequate visibility when using the device.Needle tip becoming lodged in bone.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.This is an acknowledged failure mode that has been evaluated and is being monitored through our post market surveillance.A review of the device history records associated with this manufactured lot confirmed that no abnormalities were reported with this product during manufacture.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) reportedly the surgeon unsuccessfully attempted to retrieve the truepass needle tip, creating a >30-60 minute procedural delay.The device has not been returned for analysis.It was reported that the breakage of the needle tip and the extended surgery time did not result in any patient harm.The patient did not require any additional medical intervention and no additional harm is anticipated.No further clinical assessment is warranted in this case.

• 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: 8162760
• MDR Text Key: 130466146
• Report Number: 1219602-2018-01758
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885554030433
• UDI-Public: 00885554030433
• 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: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

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 Expiration Date: 07/18/2019
• Device Catalogue Number: 72203793
• Device Lot Number: 50512635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2014
• 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