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

Catalog Number	0113120
Medical Device Problem Codes	Use of Device Problem (1670); Expiration Date Error (2528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported the expired device was used in error.A review of our records shows that the device was well within the date of expiry (01/28/2019) when provided to the facility on 07/04/2017.The expiration date is located on multiple layers of the packaging.This event is confirmed for user related.The ifu instructs the user to do not use beyond the expiration date of the product.
Event or Problem Description
It was reported that an expired permafix fixation device was accidentally used during a procedure and this was not realized until after the surgery.The customer was looking for advice on the expiration date as to whether it pertained to the sterility or product integrity.The user facility was planning to speak with the patient and their own management and legal team.No adverse outcomes were reported as a result of this event.

• Brand Name: PERMAFIX FIXATION SYSTEM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8545971
• Report Number: 1213643-2019-03331
• Device Sequence Number: 11195200
• Product Code: GDW
• UDI-Device Identifier: 00801741016721
• UDI-Public: (01)00801741016721
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2019
• Device Catalogue Number: 0113120
• Device Lot Number: HUAN1049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1