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

Catalog Number	0113116
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a procedure on (b)(6) 2026, the sorbafix fixation device malfunctioned and the fasteners could not be fastened.Another device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, the sorbafix fixation device malfunctioned and failed to fixate.Evaluation of sample finds as received the device failed to deploy fasteners.The remaining fasteners were found to be bound to the mandrel as a result of the device becoming temperature exposed.It cannot be determined if the device was exposed prior to use or during the sample return transit.Internal component review found the input clutch gear was deformed which resulted in the performance issue reported.Based on the sample evaluation probable cause for the reported failure to fixate is forces applied while in use resulting in broken gear teeth.No manufacturing anomalies were found.Review of manufacturing records confirms the product was manufactured to specification.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for successful fastener delivery.The storage section of the ifu supplied with the device states, "store the sorbafix¿ absorbable fixation system at room temperature.Avoid prolonged exposure to elevated temperatures." and the precautions section states, "avoid excessive trigger force as this may damage the device." 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: 24388978
• Report Number: 1213643-2026-00188
• Device Sequence Number: 21462309
• Product Code: GDW
• UDI-Device Identifier: 00801741016707
• UDI-Public: (01)00801741016707(11)250124(17)261228(10)HUKN1268
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

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: 0113116
• Device Lot Number: HUKN1268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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