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 Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Rupture (2208); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a ent surgery, the suturefix anchor came out from the bone while tying the knot, the anchor was successfully removed from the bone.A new bone hole was made and the other anchor was placed.The procedure was successfully completed without a significant delay.No other complications were reported.

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a ent surgery, the suturefix anchor came out from the bone while tying the knot, the anchor was successfully removed from the bone.A new bone hole was made and the other anchor was placed.The procedure was successfully completed without a significant delay.No other complications were reported.

Manufacturer Narrative

Additional information ¿h6: health effect - clinical code, medical device problem code¿ the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review found 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.After three attempts no relevant clinical information nor the device has been provided, therefore, a thorough medical investigation cannot be rendered nor could a definitive root cause of the reported failure be determined.According to the report, the anchor was successfully removed from the bone and a new bone hole was created and another anchor was placed.It was reported, the procedure was successfully completed without a significant delay.Since no other complications were reported, no further clinical/medical assessment is warranted at this time.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed, and the root cause could not be determined.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• 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 ; 5123913905
• MDR Report Key: 13477359
• MDR Text Key: 285224623
• Report Number: 1219602-2022-00171
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• 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: 2073041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Date Device Manufactured: 05/18/2021
• 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: 28 YR
• Patient Sex: Male