MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS WITH ARTHROSCOPIC DELIVERY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	4403
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an arthroscopy procedure using regeneten, the surgeon wanted to place the tendon anchor to secure the regeneten patch, but failed to successfully slot in the tendon anchors in the inserter.At the beginning it was smooth but after multiple times of slotting in the tendon anchors in the inserter, it was observed that the tendon anchor arms were tore in the container while trying to slot in with the inserter.The procedure with regeneten device was cancelled and it was closed by doing debridement.There was a delay within 30 mins.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).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 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, no clinical factors were found which would have contributed to the reported events.The bone anchors are implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.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.H11: corrected information in h6 (health effect - impact code).
Event or Problem Description
It was reported that during an arthroscopy procedure using regeneten, the surgeon wanted to place the tendon anchor to secure the regeneten patch, but failed to successfully slot in the tendon anchors in the inserter.At the beginning it was smooth but after multiple times of slotting in the tendon anchors in the inserter, it was observed that the tendon anchor arms were tore in the container while trying to slot in with the inserter.No broken pieces remain inside the patient.The procedure with regeneten device was cancelled and it was closed by doing debridement.There was a delay within 30 mins.

• Brand Name: BONE ANCHORS WITH ARTHROSCOPIC DELIVERY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 16838339
• Report Number: 3003604053-2023-00019
• Device Sequence Number: 6870727
• Product Code: LXH
• UDI-Device Identifier: 00854501006159
• UDI-Public: 854501006159
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K131635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/15/2025
• Device Catalogue Number: 4403
• Device Lot Number: 2096110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 11/27/2023
• Date Device Manufactured: 07/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown