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

Catalog Number 72203793

Device Problems Break (1069); Unintended Collision (1429); Misfire (2532)

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

Event Date 07/08/2015

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).

Event Description

During a rotator cuff repair, it was reported that the device misfired several times while in use and the surgeon had a needle tip break after hitting bone.The doctor suspects that there is something wrong with the trigger.The broken tip was retrieved and with the use of fluoroscopy at the end of the case, revealed no metal or debris left in the patient.When the device was reloaded with another needle, the surgeon stated that the device was not passing suture in the cuff as it had done without issue in previous cases.He has been using the truepass since last october without issue.The surgeon told the scrub tech to load a new needle into the passer thinking that they had a bad needle however they experienced the same result.The scrub tech was able to pass the needle on the back table however, not when in the patient.A back-up was available to complete the procedure.There was no reported delay, patient injury or surgical complication.

Manufacturer Narrative

Device is not being returned for evaluation.Clinical details report that the needle tip broke after it came in contact with a bony structure.Per the device ifu under precautions "ensure adequate visibility when using the device.Should the needle tip become lodged (e.G., in bone), the needle should be disengaged by retracting it back through the suture passer.Twisting or bending of the needle in an attempt to dislodge the needle tip may result in breakage of the needle and needle parts may not be retrievable.Discard the needle and use a new needle".Further investigation is not warranted at this time.(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 ; smith & nephew, inc.; andover, MA 01810 ; 5123585706
• MDR Report Key: 5000488
• MDR Text Key: 23136641
• Report Number: 1219602-2015-00793
• 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: Physician
• Type of Report: Followup
• Report Date: 07/17/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72203793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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