MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA PAC 1.2; PASSER

Catalog Number 72202799

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

It was reported that during acl reconstruction surgery, the endobutton ultra´s guide pin broke off inside patient´s bone.The broken pieces were left inside the patient.It is unknown if there was a back up device available or if there was a surgical delay.No further complications were reported.

Manufacturer Narrative

H10: h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A clinical review states that based on the information provided, the definitive clinical root cause of the reported breakage cannot be determined.The retained broken endobutton ultra´s guide pin is manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.It was reported the broken guide pin was left inside of the patient¿s bone, therefore, the impact to the patient is the potential for micro-motion/migration, though unlikely as it's contained within the patient¿s bone.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: ENDOBUTTON CL ULTRA PAC 1.2
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18120992
• MDR Text Key: 327942253
• Report Number: 1219602-2023-02219
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010657626
• UDI-Public: 03596010657626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202799
• Device Lot Number: 2085198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Date Device Manufactured: 01/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other