MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MINITACTI 2.0 HS STR ANCHR 2 DRBRD NDL; STAPLE, FIXATION, BONE

Model Number 7210303

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/29/2020

Event Type  Injury  

Event Description

It was reported that during soft tissue fixation of finger joint procedure, it was found that the suture with needle was broken during fixation.No delay and a back up was available to complete the procedure in the same bone hole.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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 specifications found that a material certification is required with each lot.A visual inspection of the returned device found that it is not in its original packaging.The green suture is split in two, and is frayed on the ends.The white suture has a clean cut through the middle with no fraying.There is debris on the sutures.The needles are still attached to the sutures.Based on the condition of the product material found during visual inspection, additional material testing is not required.A review of the customer provided image found labelling confirming the product identification information.The sutures and anchor are in a glove, but no damage can be seen.The material composition for the device needle is 302 stainless steel.Consequently, we are unable to make any conclusions on the impact of the possibly retained non-implantable foreign body.However, if the non-implantable portions of the device were retained inside of the patient¿s body, the potential for micro-motion and/or migration, and local skin irritation/discomfort cannot be ruled out.No patient harm has been alleged.Therefore, no further clinical/medical assessment can be rendered at this time.Should any additional clinically relevant medical information be provided, this case may 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 or torsion during use or use of sharp instruments near the device tip.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: MINITACTI 2.0 HS STR ANCHR 2 DRBRD NDL
• Type of Device: 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: 10720128
• MDR Text Key: 212548833
• Report Number: 1219602-2020-01637
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010533029
• UDI-Public: 03596010533029
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: 7210303
• Device Catalogue Number: 7210303
• Device Lot Number: 50752517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 75 KG