MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SORBAFIX ABSORBABLE FIXATION SYSTEM; STAPLE, IMPLANTABLE

Catalog Number 0113116

Device Problems Shelf Life Exceeded (1567); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2017

Event Type  malfunction  

Manufacturer Narrative

As reported the expired device was implanted in error.A review of our records shows that the device was well within the date of expiry (05/28/2016) when provided to the facility in 2014.This event is confirmed for use related.The ifu instructs the user to do not use beyond the expiration date of the product.Not returned.

Event Description

It was reported that on (b)(6) 2017, an expired sorbafix fixation device was used on a patient in error.Device was provided to the user facility on (b)(6) 2014.The surgeon has elected to take no action and shall monitor the patient.No adverse outcomes have occurred as a result of this event.

• Brand Name: SORBAFIX ABSORBABLE FIXATION SYSTEM
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: anna smith ; 100 crossings blvd.; warwick, RI 02886 ; 4018258449
• MDR Report Key: 7011716
• MDR Text Key: 92605232
• Report Number: 1213643-2017-00807
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00801741016707
• UDI-Public: (01)00801741016707(17)160528(10)HUYD0985
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K111153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Catalogue Number: 0113116
• Device Lot Number: HUYD0985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• 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 Age: 57 YR