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

Catalog Number	72205021
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4) d4, lot no.: the following are the lot numbers reported: 51059658 (2 devices), 51079977 (1 device) however, it is unknown which of the 3 contributed with the delay greater than 30 minutes.D4, exp.Date: expiration dates for each of the 2 lots reported: 23-aug-2025 (2 devices), 03-nov-2025 (1 device).H4, mgf.Date: manufacturing dates for each of the -x quantity-lots reported: 23-aug-2022 (2 devices), 03-nov-2022 (1 device).
Event or Problem Description
It was reported that, during a shoulder stabilization procedure, three (3) microcrater knotless anchors would not deploy.The black knob on the inserter of the first device would not rotate, then, an attempt was made with a second device, however, the same problem occurred, a third device was tested outside the patient and the black knob would not rotate.Surgery was completed after a significant delay, using a back-up device in the originally drilled bone hole.No void was left in the patient and no further complications were reported.
Additional Manufacturer Narrative
H6: the reported device was received for evaluation.A visual inspection of the returned devices found that they are not in their original packaging.Device 1 was returned with no anchor or suture material.Device 2 was returned with the distal anchor on the suture threader but no suture material.Both devices have biological debris on them.A functional assessment of the returned devices found they both actuate as intended when the knob is turned.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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18124639
• Report Number: 1219602-2023-02221
• Device Sequence Number: 20762231
• Product Code: MBI
• UDI-Device Identifier: 00885556722527
• UDI-Public: 00885556722527
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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 Catalogue Number: 72205021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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