MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYNOMITE 2.0 PK W/NDL 12-0 ULTRABRAID; STAPLE, FIXATION, BONE

Catalog Number	72201881
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during set up, when opening the box, the dynomite 2.0 pk implant and thread were separated.There was a back-up device available, and there was a non-significant delay reported.There was no patient involvement.
Additional Manufacturer Narrative
H2: additional information: h6: medical device problem code.H3, h6: the reported device was received for evaluation.A visual inspection revealed it was returned in original packaging with the batch number of the complaint on the label.The anchor and suture are off the insertion device, the anchor is slightly deformed at its proximal end.A functional evaluation could not be performed due to the anchor has already been deployed.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.A review of the assembly procedure found that the anchor is threaded with the suture and the anchor/suture/needle assembly is attached to the shaft tip.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include an unintended impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: DYNOMITE 2.0 PK W/NDL 12-0 ULTRABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 18217149
• Report Number: 1219602-2023-02314
• Device Sequence Number: 20486514
• Product Code: JDR
• UDI-Device Identifier: 03596010619068
• UDI-Public: 03596010619068
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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: 72201881
• Device Lot Number: 2101799
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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