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

Catalog Number	72205020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Periprosthetic fracture (4902)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates 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 conservatively 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 unspecified procedure, when the surgeon was inputting the microraptor knotless anchor in the superior labrum.He drilled off axis and there was poor bone quality, so when he put in the anchor he went through the anterior-superior corner of the glenoid, broke off the corner of the bone, and lost the anchor's body.The peek tip and suture were recovered, but lost the rgsb body.The body was fully intact as was last seen on the camera.It is unknown if there was a back up device available or if there was a surgical delay.No further complications were reported.
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.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, a clinical review states that the clinical root cause was the result of a user technique vs procedural variance based on the report that the surgeon drilled off axis into what was noted as poor bone quality.The microraptor knotless anchor is implantable, so biocompatibility is not an issue.Local irritation/discomfort should not be ruled out.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.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.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 composition device component found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.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.There is a definitive clinical root cause.Factors that could have contributed to the reported event include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Based on this investigation, the need for corrective action is not indicated.

• 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: 21056202
• Report Number: 1219602-2025-00007
• Device Sequence Number: 21028423
• Product Code: MAI
• UDI-Device Identifier: 00885556722510
• UDI-Public: 885556722510
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2025

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: 10/06/2025
• Device Catalogue Number: 72205020
• Device Lot Number: 51072379
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 12/13/2024; 03/11/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/02/2025; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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: Other
• Patient Sex: Unknown