MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR S 2 UB STR CB BLU; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72203853

Device Problem Firing Problem (4011)

Patient Problems Perforation (2001); Unspecified Tissue Injury (4559)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the bankart repair case, it was noticed that there was a major defect with suturefix ultra anchor.The anchor could not be deployed since the product was already damaged before usage.A backup device was used in additional bone hole and no delay or patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.An analysis of the customer provided image revealed that the suture anchor is loose and pushed to one side due to prong being broke off of device.A visual inspection revealed the device was returned with original packaging.The anchor and suture thread are still in place.Further review found device trigger does not slide smoothly as it should.Also, it was found that anchor and suture were shifted to one side at the tip of device due to one of the prongs that hold anchor in place is broken off.No other physical damage visible to the device.A functional evaluation of the returned device did not allow for a functional evaluation of 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate a review of the procedure found that each component should be visually inspected for all non-conforming attributes defined in the procedure.It was determined the device did not contribute to the reported event.Based on the information provided, a backup device was used in an additional bone hole to complete the procedure without delay or patient injuries.The impact to the patient beyond the additional bone hole cannot be determined.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant clinical 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, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.Correction in h6 evaluation codes.

• Brand Name: SUTUREFIX ULTRA AHR S 2 UB STR CB BLU
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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
• MDR Report Key: 11271798
• MDR Text Key: 230014938
• Report Number: 1219602-2021-00247
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554031447
• UDI-Public: 00885554031447
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203853
• Device Catalogue Number: 72203853
• Device Lot Number: 2046737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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