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

Catalog Number	72205021
Medical Device Problem Codes	Difficult to Insert (1316); Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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 a foot and ankle surgery, the tail end of the microraptor knotless anchor could no longer rotate.The anchor was removed from the patient, the surgery was completed using a rejoin competitor device in the original drilled bone hole, there was a surgical delay of less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H2: corrected information in h6 (investigation findings).H3, h6: the reported device was not returned to the designated complaint unit for independent 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 no 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.However, an image evaluation was performed and found that the rotation deficiency can not be evaluated.However, the device has a bent distal implant with debris left.The root cause of the bent distal implant could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
Corrected information in h6 (medical device problem code).
Additional Manufacturer Narrative
H2: corrected information in h6 (medical device problem code & type of investigation).H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was returned in opened original packaging with the batch number of the complaint on the label.The distal body anchor and the proximal screw were not returned.The insertion device had no visible defect.Bio debris was present.A functional evaluation was performed on the returned device and found the gray knob is completely deployed and locked.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 no 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.An image evaluation was performed and found that the rotation deficiency could not be evaluated.However, the device has a bent distal implant with debris left.A definitive root cause for the failures could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: MICRORAPTOR KNOTLESS SA PEEK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22329280
• Report Number: 1219602-2025-01605
• Device Sequence Number: 12834249
• Product Code: MBI
• UDI-Device Identifier: 00885556722527
• UDI-Public: 885556722527
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2025
• Device Catalogue Number: 72205021
• Device Lot Number: 51083252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 07/29/2025; 12/17/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/30/2025; 08/01/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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
• Patient Sex: Unknown