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

Model Number	72201881
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case- (b)(4).
Event or Problem Description
It was reported that during a mbo surgery, the thread of the dynomite broke while the knot was being made.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed the device was returned with original packaging and the device has debris on it.Thread materials do appear to be frayed as if thread was broken no physical damage is visible to the device.A functional evaluation of the returned device found that device is in working order.Device passed all functional test, device functioned as per manufacture spec.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.A review of the raw material found the storage requirements, material specifications, and material tests were appropriately documented.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.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed, 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.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
• MDR Report Key: 12493509
• Report Number: 1219602-2021-02059
• Device Sequence Number: 19142386
• Product Code: JDR
• UDI-Device Identifier: 03596010619068
• UDI-Public: 03596010619068
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 12/04/2025
• Device Model Number: 72201881
• Device Catalogue Number: 72201881
• Device Lot Number: 2063781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 09/19/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other