MAUDE Adverse Event Report: ARTHROCARE CORPORATION DISP FIRSTPASS STR PASSR SELF; PASSER

Catalog Number	22-4038
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	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, it was noticed that the metal piece on the firstpass suture capture fell off the device.The procedure was resumed, using an equivalent s+n back-up.It is unknown if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H11, h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found one picture of the jaw next to a broken piece of metal.The second picture shows the packaging of the device with the lot number on it.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include (application of unintended inappropriate or excessive force to the device).Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: internal complaint reference: case- (b)(4).B5 and h6 updated.
Event or Problem Description
It was reported that during a procedure, it was noticed that the metal piece on the firstpass suture capture fell off the device.The piece fell into the patient and was retrieved with a grasper.The procedure was resumed, after a no-significant delay using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned with any original packaging.The suture capture has been disconnected from the upper jaw.The suture capture was not returned.Bio debris is present.No other visual deficiencies.A functional evaluation showed pulling the lever will close and lock the jaw.Pulling the lever and trigger simultaneously will deploy the suture passer needle.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include (application of unintended inappropriate or excessive force to the device).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Common Device Name: PASSER
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23280143
• Report Number: 3006524618-2025-00587
• Device Sequence Number: 15643781
• Product Code: HWQ
• UDI-Device Identifier: 00885556724545
• UDI-Public: 885556724545
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/06/2026

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: 22-4038
• Device Lot Number: 2164873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 10/31/2025; 11/05/2025; 02/05/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/05/2025; 11/06/2025; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2024
• 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
• Patient Sex: Unknown