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); Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation at this time.Without the subject product, we are unable to determine a root cause or probable root cause of the permafix device misfiring/failing to fixate.If/when the device is returned for evaluation, a supplemental mdr will be sent.Review of the dhr showed component acceptability and traceability were confirmed through incoming inspection records for traceable components used.All process steps were completed per manufacturing procedures and met specification.Lot qty.(b)(4) units.There have been no other complaints reported for this lot to date.Device not available for evaluation.
Event or Problem Description
It was reported that during a laparoscopic inguinal tapp procedure, the permafix failed to fire after the first fastener was deployed.The fastener that was deployed did not provide adequate fixation, however there were no broken, loose or proud fasteners in the body as a result of the problem.There was a prolongation of the case while the surgeon obtained another permafix device to complete the procedure.As reported, there was no injury or impact to the patient.

• 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: 9914237
• Report Number: 1213643-2020-03154
• Device Sequence Number: 16991194
• Product Code: GDW
• UDI-Device Identifier: 00801741016714
• UDI-Public: (01)00801741016714
• Combination Product (Y/N): N
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2020

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: 05/28/2022
• Device Catalogue Number: 0113119
• Device Lot Number: HUDT0188
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR