MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERMAFIX ENHANCED; STAPLE, IMPLANTABLE

Catalog Number	0113120
Medical Device Problem Codes	Break (1069); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was retuned in a condition that makes functional analysis impossible.Additional information was requested, but not provided.Review of the device history records found no anomalies, the lot (qty.415, released to stock aug 2020) was manufactured to specification.The instructions-for-use (ifu) identify contraindications associated with laparoscopic and open surgical procedures relative to mesh fixation apply, including but not limited to fixation of bone and cartilage.The cause of the reported broken fasteners in use cannot be determined at this time and no conclusions can be made.To date, this is the only reported complaint for this manufacturing lot.
Event or Problem Description
As reported, during unknown procedure on (b)(6) 2021, the bard/davol permafix fixation device deployed half a piece of fastener (broken fastener) each time.There was no reported patient injury.
Additional Manufacturer Narrative
The device was retuned in a condition that makes functional analysis impossible.Additional information was requested, but not provided.Review of the device history records found no anomalies, the lot (qty.(b)(4), released to stock aug 2020) was manufactured to specification.The instructions-for-use (ifu) identify contraindications associated with laparoscopic and open surgical procedures relative to mesh fixation apply, including but not limited to fixation of bone and cartilage.The cause of the reported broken fasteners in use cannot be determined at this time and no conclusions can be made.To date, this is the only reported complaint for this manufacturing lot.Addendum: h.11 this is an addendum to the initial mdr submitted.Based on additional information provided there has been clarification of the actual event that occurred.As such, this supplemental mdr is submitted to document this information.Corrected fields: b5 (event description), h6 (imdrf annex a, annex g).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd h3 other text : sample evaluated.
Event or Problem Description
As reported, during unknown procedure on (b)(6) 2021, the bard/davol permafix fixation device deployed half a piece of fastener (broken fastener) each time.There was no reported patient injury.Addendum per additional information: as reported, during a general surgery procedure, the surgeon attempted to deploy the first fastener of the permafix device by pulling the handle and no fastener was released from the device.As reported, the device was not used on the patient.It was reported that another permafix fixation device was used to complete the procedure.

• Brand Name: PERMAFIX ENHANCED
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 12935560
• Report Number: 1213643-2021-20450
• Device Sequence Number: 5737231
• Product Code: GDW
• UDI-Device Identifier: 00801741016721
• UDI-Public: (01)00801741016721
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: 06/28/2023
• Device Catalogue Number: 0113120
• Device Lot Number: HUET1663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown