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

Catalog Number	0113115
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a tapp procedure when fixating the mesh in the preperitoneal space, sorbafix enhanced devices (device #1 and device #2) deployed more than one fastener at a time.It was reported that no fasteners have been fixated from both devices and one fastener was broken (device #2).It was also reported that the broken fastener was not removed from the patient's body.The surgeon has high level of experience, and the procedure was completed by using another brand device.There was no patient injury.This file represents device #1.
Additional Manufacturer Narrative
As reported, sorbafix deployed more than one fastener at a time.It is reported that the subject device is being returned for evaluation; however, at this time it has not been received.Based on the information provided and without having the sample to evaluate, no conclusion can be made.Review of manufacturing records shows product was made to specification.This mdr represents the sorbafix enhanced (device #1).An additional mdr was submitted to represent the sorbafix enhanced (device #2).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 a tapp procedure when fixating the mesh in the preperitoneal space, sorbafix enhanced devices (device #1 and device #2) deployed more than one fastener at a time.It was reported that no fasteners have been fixated from both devices and one fastener was broken (device #2).It was also reported that the deployed multiple fasteners and broken fastener were not removed from the patient's body.The surgeon has high level of experience, and the procedure was completed by using another brand device.There was no patient injury.This file represents device #1.
Additional Manufacturer Narrative
As reported, sorbafix deployed more than one fastener at a time.It is reported that the subject device is being returned for evaluation; however, at this time it has not been received.Based on the information provided and without having the sample to evaluate, no conclusion can be made.Review of manufacturing records shows product was made to specification.Addendum: h11: this supplemental mdr is submitted to document the sample evaluation results.Evaluation of the returned sample is inconclusive as the result of poor sample condition.The device was returned with a broken cannula shaft.For the shaft to be broken in this nature it would have been done intentionally after use with the use of significant force.Functional and simulated use testing could not be performed.No manufacturing anomalies were found.This supplemental mdr represents the sorbafix enhanced (device #1).An additional supplemental mdr was submitted to represent the sorbafix enhanced (device #2).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.

• Brand Name: SORBAFIX 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: 20675256
• Report Number: 1213643-2024-00541
• Device Sequence Number: 12997095
• Product Code: GDW
• UDI-Device Identifier: 00801741016691
• UDI-Public: (01)00801741016691(17)250728(10)HUHV1554
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 07/28/2025
• Device Catalogue Number: 0113115
• Device Lot Number: HUHV1554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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