MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG LIGHT; SURGICAL MESH

Catalog Number	0117060
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an open surgical procedure, the surgeon noted that the thread connecting the petal was frayed and detached from the perfix light plug.It was reported that the surgeon does not trim or reshape the mesh prior to its usage.As reported as there was no problem with the shape and properties of the perfix light plug and the petal was not detached from the plug as such the surgeon decided to use the mesh for the repair.There was no patient injury.
Additional Manufacturer Narrative
It was reported that the thread connecting the petal was frayed and detached from the perfix light plug.An image was provided and shows what appears to be a remnant of monofilament, such as what is used to tie the petal to the plug during manufacture.As the surgeon confirmed that the petal was secured to the plug, this monofilament may be residual material that was not identified on/in the perfix light plug.However, review of the photo does not assist in determining a definitive root cause.Based on the information available and without having the sample to evaluate, no conclusions can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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 not returned.
Additional Manufacturer Narrative
It was reported that the thread connecting the petal was frayed and detached from the perfix light plug.An image was provided and shows what appears to be a remnant of monofilament, such as what is used to tie the petal to the plug during manufacture.As the surgeon confirmed that the petal was secured to the plug, this monofilament may be residual material that was not identified on/in the perfix light plug.However, review of the photo does not assist in determining a definitive root cause.Based on the information available and without having the sample to evaluate, no conclusions can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental mdr is being submitted to document the sample evaluation results.Evaluation confirms the returned sample to be a remnant of monofilament used during manufacturing.Based on sample and manufacturing process evaluation performed, returned sample condition is determined to be a manufacturing-generated condition.Awareness dissemination was provided to all appropriate personnel.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.
Event or Problem Description
As reported, during an open surgical procedure, the surgeon noted that the thread connecting the petal was frayed and detached from the perfix light plug.It was reported that the surgeon does not trim or reshape the mesh prior to its usage.As reported as there was no problem with the shape and properties of the perfix light plug and the petal was not detached from the plug as such the surgeon decided to use the mesh for the repair.There was no patient injury.

• Brand Name: PERFIX PLUG LIGHT
• Common Device Name: SURGICAL MESH
• 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: 17817505
• Report Number: 1213643-2023-00345
• Device Sequence Number: 6161100
• Product Code: FTL
• UDI-Device Identifier: 00801741030956
• UDI-Public: (01)00801741030956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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 Catalogue Number: 0117060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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