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

Catalog Number	0113127
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	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, an unusual rattling sound was heard from the optifix straight product, sounding like a part had come loose.The subject device is being returned for evaluation, however, at this time has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made at this time.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.To date, this is the only reported complaint for this manufacturing lot of 525 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, on (b)(6) 2026, an unusual rattling sound came from the optifix straight device after opening the product, "it sounded like a part had come loose" per information reported, the issue was identified immediately after opening, so no actuation of the handle was performed.A new product was used to complete the procedure successfully.
Event or Problem Description
As reported, on (b)(6) 2026, an unusual rattling sound came from the optifix straight device after opening the product, "it sounded like a part had come loose" per information reported, the issue was identified immediately after opening, so no actuation of the handle was performed.A new product was used to complete the procedure successfully.
Additional Manufacturer Narrative
As reported, an unusual rattling sound was heard from the optifix straight product, sounding like a part had come loose.The subject device is being returned for evaluation, however, at this time has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made at this time.A review of the manufacturing records was performed and found that the lot was manufactured to the 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 to document the sample evaluation results.Based on the reported condition and sample evaluation finding, the reported condition is confirmed as manufacturing related.Evaluation found a detached loose screw within the device housing that was not fully detached during device assembly.A general awareness was provided to optifix personnel to emphasize device assembly requirements.Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.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: OPTIFIX STRAIGHT
• 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: 24456397
• Report Number: 1213643-2026-00231
• Device Sequence Number: 15944769
• Product Code: GDW
• UDI-Device Identifier: 00801741074325
• UDI-Public: (01)00801741074325(17)270528(10)HUKT1178
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142873
• 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): 03/02/2026

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: 0113127
• Device Lot Number: HUKT1178
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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