MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 HS SUTR ANCHR W/2 28" DUR; STAPLE, FIXATION, BONE

Catalog Number 72200796

Device Problem Insufficient Information (3190)

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

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a procedure when the package was opened, the tip of anchor was found to be already out of the sterile packaging.There was no delay or patient injuries but it is unknown how the procedure was finished since no backup device was available to complete it.Attempts were made to retrieve further details about the event but the complainant does not have more information.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One twinfix ti hs suture anchor device was not used for treatment but was returned for evaluation.The complaint stated: ¿the tip of anchor was found to be already out of the sterile packaging.¿ the tyvek pouch was returned still sealed.The product was not protruding from the tyvek pouch at that time, but there was a pierce where it had poked through at some point during transit.The tip protective tube, as well as the poly bag were out of location and found free floating inside the tyvek pouch.The condition was recently brought to engineering¿s awareness in order to revise the packaging for creating a more appropriate fit and removing the pouch slack for the shorter device code.The device history records and the complaint history, for this lot, were reviewed and it is concluded that the product met specifications at the time of release to distribution.

• Brand Name: TWINFIX TI 2.8 HS SUTR ANCHR W/2 28" DUR
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9249581
• MDR Text Key: 164128024
• Report Number: 1219602-2019-01334
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010584489
• UDI-Public: 03596010584489
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Catalogue Number: 72200796
• Device Lot Number: 50763859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1