MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS 3 W ARTHRO DEL SYSTEM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 4403

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Skin Inflammation/ Irritation (4545)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that after procedure, where regeneten bioinductive implant was used, the patient had pain and irritation on (b)(6) 2021.On a second surgery, it was noticed that the device become dislodged and was not secured to the supraspinatus tendon.It had bunched up and was partially attached to the acromion.The implant , bone anchors and tendon anchors were removed.The patient outcome is unknown.

Event Description

It was reported that on (b)(6) 2021 patient had a left shoulder arthroscopic rotator cuff repair using a regeneten patch.After this the patient presented pain and had to be treated with medication, injections and phyisical therapy.On (b)(6) 2021 the patient had a revision surgery where there was evidence of a midsubstance rupture of the bio inductive patch with tissue flipped on itself in the lateral glutter and also a ridge on the acromion which may have corresponded to the contact of the graft.The rupture of the patch was debrided with a combination of a shaver and grasper from the lateral portal, the 2 bone staples were removed and the soft tissue staples were also removed with a combination of a grasper and a shaver.The ridge was smoothed with a shaver.After this procedure patient presented pain again, medications were also provided.Current status of the patient is unknown.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

Internal complaint reference case-2021-00069452-3.D4: part and udi number updated.

Manufacturer Narrative

H10: internal complaint reference (b)(4).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.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 adverse event could not be determined.However, we cannot rule out the patient¿s non-compliance with the rehabilitation plan as a potential contributory factor to the reported events.Approximately seven-months post procedure this patient reports she is doing her home exercises and feels like she is improving.The patient rates her pain as 2 on a scale of 10, and she is happy with her progress.Therefore, the patient impact beyond what was reported could not be determined.All documents and images provided as of this date have been reviewed and considered, no further clinical/medical assessment is warranted at this time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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.Correction in h6 (health effect - clinical and impact codes).

• Brand Name: BONE ANCHORS 3 W ARTHRO DEL SYSTEM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 12445088
• MDR Text Key: 270478174
• Report Number: 3003604053-2021-00244
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00854501006173
• UDI-Public: 00854501006173
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2023
• Device Model Number: 4403
• Device Catalogue Number: 2503-A
• Device Lot Number: 2065152
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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): Required Intervention