MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENDON ANCHORS 8; STAPLE, IMPLANTABLE

Catalog Number	2504-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during an shoulder cuff augmentation, box of eight (8) tendon anchors broke.Three 3 broke during assembly when opening the box, and the other five (5) implants broke during application inside the patient.The broken implants remained inside the patient.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H2: additional information in b5.
Event or Problem Description
It was reported that during an shoulder cuff augmentation, box of eight (8) tendon anchors broke.Three 3 broke during assembly when opening the box, and the other five (5) implants broke during application inside the patient.The broken implants remained inside the patient.The procedure was completed using a smith and nephew back up device.There was a 30-min delay and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).H3, h6: a device deficiency was identified, the root cause of the reported event could not be determined since the device was not returned for evaluation.A clinical review states that the provided photo image of the cassettes appears to show one cassette (on the right) with 3 of the 8 anchors activated which may correlate with the reported ¿3 broke during assembly when opening the box¿.The 3-intraop scope images appear to confirm implant breakage; however, they do not confirm perpendicular contact of the inserter base to the implant for deployment of tendon anchors.Reportedly, 3 of the 8 tendon anchors were broken upon opening the box.Shipping/handling and storage are out of the manufacturer¿s control.Risks and side effects associated with the regeneten bioinductive implant are similar to the risks associated with surgical treatment of the shoulder rotator cuff.Although the tendon anchors are bioabsorbable, there are reportedly ¿3-5 fragments¿ retained/¿embedded in tissue¿ and ¿some in the joint space without access¿, therefore, there is a risk of adverse reactions such as local tissue irritation/inflammation/disruption, discomfort, and migration until the fragments are absorbed.A post-procedural restoration phase is anticipated.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 review of the anchor specifications found that a material certificate of analysis from each raw material supplier is required.Factors that could have contributed to the broken anchors upon opening the box include improper shipping/handling or storage conditions.Factors that could have contributed to the broken anchors during the application include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TENDON ANCHORS 8
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 20561580
• Report Number: 3003604053-2024-00056
• Device Sequence Number: 16913379
• Product Code: GDW
• UDI-Device Identifier: 00854501006067
• UDI-Public: 854501006067
• Combination Product (Y/N): N
• Initial Reporter Country: CJ
• PMA/510(K) Number: K131637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2504-1
• Device Lot Number: 51243640
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 11/08/2024; 12/10/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/11/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown