MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERMAFIX FIXATION SYSTEM 15 COUNT; STAPLE, IMPLANTABLE

Catalog Number	0113119
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was returned with all of the fasteners deployed from the device; therefore, a functional evaluation could not be performed.The visual evaluation found no manufacturing anomalies.A definitive root cause of the reported issue could not be determined.This is the first reported complaint for the subject lot of (b)(4) units manufactured in january of 2018.
Event or Problem Description
It was reported that while fixating a bard/davol soft mesh during a laparoscopic inguinal hernia repair, the fasteners in the permafix fixation device were coming out and were would not fixate the tissue / hold the mesh.This was tried with 5-6 fasteners and occurred repeatedly.A new fixation device was used to complete the case.There was no patient injury as a result of the problem experienced.

• Brand Name: PERMAFIX FIXATION SYSTEM 15 COUNT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9588852
• Report Number: 1213643-2020-00318
• Device Sequence Number: 16818543
• Product Code: GDW
• UDI-Device Identifier: 00801741016714
• UDI-Public: (01)00801741016714
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

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: 12/28/2020
• Device Catalogue Number: 0113119
• Device Lot Number: HUBY1096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1