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

Catalog Number	0113115
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the sorbafix enhanced fixation device fastener failed to fixate during mesh fixation, while about only one or two fasteners got fixated.The subject device is being returned for evaluation, however, at this time has not been received.Based on the information provided to date and without the sample, no conclusion can be made.Review of manufacturing records confirms product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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, the sorbafix enhanced fixation device fasteners failed to fixate to the wall during mesh fixation.The procedure was subsequently completed using an alternative device.It was also reported that approximately one or two fasteners were successfully deployed.There was no patient injury.
Additional Manufacturer Narrative
As reported, the sorbafix enhanced fixation device fastener failed to fixate during mesh fixation, while about only one or two fasteners got fixated.The subject device is being returned for evaluation, however, at this time has not been received.Based on the information provided to date and without the sample, no conclusion can be made.Review of manufacturing records confirms product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Evaluation of the returned sample finds that all fifteen fasteners are bound to the mandrel as a result of becoming exposed to elevated temperatures in transit or storage prior to use.Exactly when the device became temperature exposed could not be determined.No manufacturing anomalies were found.Based on the sample evaluation root cause is of the failure to fire is the result of attempted use of temperature exposed device.Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.Corrected fields: d4, h4.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, the sorbafix enhanced fixation device fasteners failed to fixate to the wall during mesh fixation.The procedure was subsequently completed using an alternative device.It was also reported that approximately one or two fasteners were successfully deployed.There was no patient injury.

• 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: 22608067
• Report Number: 1213643-2025-00681
• Device Sequence Number: 10106569
• Product Code: GDW
• UDI-Device Identifier: 00801741016691
• UDI-Public: (01)00801741016691(11)240308(17)260228(10)HUJQ0890
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 07/30/2025

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: 02/28/2026
• Device Catalogue Number: 0113115
• Device Lot Number: HUJQ0890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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