MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR S W/2 UB STR 1 BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72203854

Device Problems Device Dislodged or Dislocated (2923); Expulsion (2933)

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

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, during surgery, the "1.9mm suturefix anchor" came out after its deployment.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.

Event Description

It was reported that, during arthroscopic bankart repair , the "1.9mm suturefix anchor" came out after its deployment.The procedure was successfully completed without significant delay using a back-up device (same size, in different hole).The patient current status is good.No further complications were reported.

Manufacturer Narrative

H10: h3: additional information in b5.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, 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 concluded this was a repeat issue.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 review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event 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.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was returned with original packaging.The suture anchor is loose from device and has debris on it.The device has been deployed.No physical damage visible to the device.A functional evaluation of the returned device found that device has been actuated therefore no function test can 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 per the complaint details, currently we are unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.Based on the information provided, the procedure was successfully completed without significant delay using a back-up device (same size, in different hole).Per the complaint, the surgeon reported, ¿i left the void because if i used the same bone hole, the anchor would come of the hole again.¿ since it was reported the patient¿s status is good, and no other complication were reported, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this case would be re-assessed.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed, 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.

Manufacturer Narrative

Correction in h6: (health effect - clinical code | health effect - impact code | medical device problem code).

• Brand Name: SUTUREFIX ULTRA AHR S W/2 UB STR 1 BL
• 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 ; 5123913905
• MDR Report Key: 12652651
• MDR Text Key: 277110265
• Report Number: 1219602-2021-02317
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554030044
• UDI-Public: 00885554030044
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203854
• Device Catalogue Number: 72203854
• Device Lot Number: 2069167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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
• Patient Age: 37 YR
• Patient Sex: Male