MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MICRORAPTOR KNOTLESS SA RGNSB; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72205020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a left hip arthroscopy and gluteal repair, during the implantation of two (2) microraptor knotless suture anchors, some portions of the devices broke off.It is unknown how was the procedure completed and if there was a surgical delay due to the reported events, no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a left hip arthroscopy and gluteal repair, during the implantation of two (2) microraptor knotless suture anchors (b)(4), some portions of these devices broke off.The broken sections were retrieved from the patient with arthroscopic grasper.The procedure was successfully completed with non significant delay using back-up anchors in the same originally drilled bone holes.No further complications were reported.
Event or Problem Description
It was reported that during a left hip arthroscopy and gluteal repair, during the implantation of two (2) microraptor knotless suture anchors (case-2022-00113118-1) some portions of these anchors broke off.The broken sections were retrieved from the patient with arthroscopic grasper.The procedure was successfully completed with no surgical delay using back-up anchors in the same originally drilled bone holes.No further complications were reported.
Additional Manufacturer Narrative
H10: b5 and h6 (health effect - clinical code) updated.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 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the anchor, microraptor knotless, distal found that a statement of (c of c) or evidence of conformance to the material and processing specifications must be provided.A clinical review states per case details, the broken anchor was retrieved from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported 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: MICRORAPTOR KNOTLESS SA RGNSB
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15135997
• Report Number: 1219602-2022-01079
• Device Sequence Number: 12070895
• Product Code: MAI
• UDI-Device Identifier: 00885556722510
• UDI-Public: 00885556722510
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K181746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2025
• Device Model Number: 72205020
• Device Catalogue Number: 72205020
• Device Lot Number: 51026277
• 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: 07/08/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 09/27/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/15/2022; 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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 Age: 43 YR
• Patient Sex: Female