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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the dynomite pk anchor broke.The procedure was completed with a s+n back up device.It is unknown if there was a surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However an image evaluation was performed and found the device anchor is broken.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 polymer specifications, found that the raw material strength requirements and storage requirements are specified and each lot must be accompanied by a material certificate of analysis.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 rough handling or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was not received for evaluation.However, another device was received.A visual inspection of this device revealed it was returned in original packaging with the batch number of the complaint on the label.The anchor returned with the complaint is not a dynomite 2.0 peek, it is for a footprint device.It has bio debris.The distal plug has been deployed.The tip has been fractured.The two sutures, two needles, and the insertion device have no visible defect.A material assessment of the dynomite peek anchor could not be performed due to the part not being returned for 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.A review of the material specification found that the raw material strength requirements and storage requirements are specified and each lot must be accompanied by a material certificate of analysis.An analysis of the customer provided image shows the device anchor is broken.The root cause 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 excessive force or torsion during use, use of sharp instruments near the device tip, or twisting of the tip that could lead to the needle cutting across the suture.Based on this investigation, the need for corrective action is not indicated.H11: corrected information in h6 (correction).

• 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: 19657540
• Report Number: 1219602-2024-01414
• Device Sequence Number: 17779487
• Product Code: JDR
• UDI-Device Identifier: 03596010619068
• UDI-Public: 03596010619068
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2024

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: 2123133
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 12/04/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/07/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• 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 Age: 31 YR
• Patient Sex: Male
• Patient Weight: 66 KG