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

Catalog Number 72205205

Device Problems Connection Problem (2900); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an arthroscopy surgery, it was noticed that the bone anchor didn¿t sit flat.It appeared that the flutes had been pushed back outside the anchor.Seeing that the anchors were not holding regeneten in place, the surgeon removed the regeneten implant entirely by using a grasper.The procedure was completed without a significant delay and by changing the initial technique.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H10: internal complaint reference: (b)(4).Correction in h6 (medical device problem code).

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection of the returned device finds the entire system was returned.Included were the bone anchor insertion device; 3 bone anchor drivers; a bone punch; 2 tendon anchor insertion devices; a tendon staple loader; 2 cannulas with the applicable obturators; the tendon stabilizing guide; and a partial bioinductive implant were returned.One of the bone anchor drivers has the distal end deformed and another has a partial anchor still on the device.4 of the 8 tendon staples have been removed from the tendon anchor insertion device.There is biological debris on the returned items.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 user technique cannot be ruled out as a contributing factor to the reported events, as during the initial placement of the regeneten, most of the regeneten anchors had not purchased through the tendon.The 11 anchors used for the arthroscopic repair prior to the regeneten placement, with 7 of those anchors being in the plain that the regeneten was being placed, cannot be ruled as a contributing factor to the regeneten anchors not sitting flat.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: BONE ANCHORS 3 W ARTHRO DEL SYS ADVNCD
• 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: 11773233
• MDR Text Key: 249030744
• Report Number: 3003604053-2021-00176
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556733547
• UDI-Public: 885556733547
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2023
• Device Catalogue Number: 72205205
• Device Lot Number: 2057751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• 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