MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS WITH ARTHROSCOPIC DELIVERY; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	4403
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a rotator cuff repair procedure had been performed on (b)(6) 2021, the patient experienced some stiffness.During that case the surgeon believed that the tip of the regeneten bone anchor inserter might have broken, surgeon changed to open repair a used fluoroscopy to confirm that nothing was left behind.The patient came back with an x-ray from an outside imagining facility and it showed some artifacts that could not be made out, but the surgeon believed that this was due to the patient wearing a shirt, and not because of the inserter.The current health status of the patient is stable.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H2: additional information ¿e1: email¿.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.This case reports that the inserter of the bone anchor may have been retained in the patient.Although the case reports x-rays show ¿some artifacts¿ the images were not provided for review.No clinical information has been provided to confirm the reported events and without the requested information, the reported possible breakage could not be further assessed.The tip of the regeneten bone anchor inserter is made of 17-7 ph ss and the staple stakes on the device are se nitinol.The inserter is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported device breakage and possible retained foreign body could not be definitively determined.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.

• Brand Name: BONE ANCHORS WITH ARTHROSCOPIC DELIVERY
• Common Device Name: 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: 15001846
• Report Number: 3003604053-2022-00024
• Device Sequence Number: 1753221
• Product Code: MBI
• UDI-Device Identifier: 00854501006159
• UDI-Public: 854501006159
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K140300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2024
• Device Catalogue Number: 4403
• Device Lot Number: 2075117
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/26/2022
• Date Device Manufactured: 06/21/2021
• 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: Required Intervention
• Patient Sex: Unknown