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

Catalog Number	0113330
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, on (b)(6) 2022 the optifix at fixation device was noted to have "plastic strings" coming out of the fixation device handle.As reported the device was not used on the patient.
Additional Manufacturer Narrative
As reported, the optifix at was noted to have "plastic strings" coming out of the fixation device handle.The subject device was returned confirming the presence of the plastic string coming out from the device handle.At this time a definitive root cause cannot be made, root cause analysis is ongoing.When completed, a supplemental mdr will be submitted.
Event or Problem Description
As reported, on 22-dec-2022 the optifix at fixation device was noted to have "plastic strings" coming out of the fixation device handle.As reported the device was not used on the patient.
Additional Manufacturer Narrative
As reported, the optifix at was noted to have "plastic strings" coming out of the fixation device handle.The subject device was returned confirming the presence of the plastic string coming out from the device handle.At this time a definitive root cause cannot be made, root cause analysis is ongoing.When completed, a supplemental mdr will be submitted.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, confirmed the plastic material found to be a residual from the manufacturing process.The material found would not go unnoticed by the user prior to use resulting in the need to switch out the device.Root cause of the defect is determined to be related to operator error during the manufacturing process.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june,2022.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 evaluated.

• Brand Name: OPTIFIX AT
• 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: 16186413
• Report Number: 1213643-2022-00834
• Device Sequence Number: 2634036
• Product Code: GDW
• UDI-Device Identifier: 00801741136566
• UDI-Public: (01)00801741136566
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K191287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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 Expiration Date: 04/28/2024
• Device Catalogue Number: 0113330
• Device Lot Number: HUGS2507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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