MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRATAPE 2MM COBRD BLUE 38 PKG OF 6; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	72203897
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that during an acromioclavicular reduction from anterior to posterior, when tying to fix the reduction and making the second knot, without force, the ultratape 2mm cobrd blue broke.An attempt was made to pass the longest strip again but it broke again.The broken pieces were removed.The procedure was completed without significant delay using a back-up device.No other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 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 suture found material specifications, lot traceability requirements, that the sutures must be visually inspected for all non-conforming attributes defined in the procedure.Each shipment must have a manufacturers certificate of conformance.Fiber tenacity, linear density, knot break strength, and diameter must be certified.A visual inspection of the returned device found that it was not returned in its original packaging.The suture is fractured in the middle and is frayed near the fracture.There is debris on the suture.Based on the condition of the product material found during visual inspection, additional material testing is not required.Since there were no other complications reported, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this complaint would be re-assessed.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, inadvertent contact with a sharp edge, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: ULTRATAPE 2MM COBRD BLUE 38 PKG OF 6
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 12540959
• Report Number: 1219602-2021-02153
• Device Sequence Number: 20123576
• Product Code: GAT
• UDI-Device Identifier: 00885554031645
• UDI-Public: 00885554031645
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K132357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: 04/03/2025
• Device Model Number: 72203897
• Device Catalogue Number: 72203897
• Device Lot Number: 2053939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male