MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W ARTHRO DEL LRG; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number 72205307

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 07/20/2023

Event Type  Injury  

Event Description

It was reported that a right achilles tendon endoscopic debridement and excision of haglund¿s lesion was performed using a bioinductive implant.Prior to the procedure, on exam the patient¿s right ankle was tender and swollen over ta insertion, achilles tendon intact, mid-substance non tender, posterior impingement negative, and nv intact.Patient was found to have high grade partial tear, achilles tendinopathy and haglunds lesion.Surgeon performed the procedure, and removed the small haglunds endoscopically, then made a small incision the size of the length of the regeneten implant to place it.The implant was secured using 8 tendon anchors.After 3 weeks of operation, patient had serious discharge over the wound side even though wounds were healed and sto was done.It was swabbed for culture, but the result was negative.Surgeon removed the stitches, and the patient was provided with oral augmentin; however, patient couldn¿t tolerate it and was vomiting.Therefore, the issue was treated with 3 days of iv and 5 days of oral, and it settled down.Wound was dried up after 3 weeks.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Internal complaint reference (b)(4).H10 h3, 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.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found 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 the provided photo was reviewed and is consistent with the reported serous drainage.The provided undated diagnostic images were reviewed and the x-ray does not show a root cause but the other image (could be mri) does indicate location of the achilles tear however does not aid in the investigation as they do not provide insight into a clinical root cause to the reported serous drainage.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Conclusion: although the reported serous drainage 3-weeks postop had a negative culture, the surgeon treated it with i/v and oral antibiotics, which may indicate a possible bacterial infection.It cannot be concluded the reported serous fluid was associated with the regeneten implant versus serious exudate as part of surgical wound closing.The reported event was resolved after 3-weeks; therefore, no further patient impact is anticipated.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: BIOINDUCTIVE IMPLANT W ARTHRO DEL LRG
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18346832
• MDR Text Key: 330737481
• Report Number: 3003604053-2023-00085
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72205307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ORAL ANTIBIOTICS, INTRAVENOUS ANTIBIOTICS.
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female