MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN ENDOBUTTON DEVICE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Fistula (1862)

Event Date 04/12/2014

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).Heredia, j.D., iban, m.R., gutiérrez, r.C., diaz, r.R., del val, i.C.M., & merino, l.T.(2014).Early postoperative transtibial articular fistula formation after anterior cruciate ligament reconstruction: a review of three cases.Archives of orthopaedic and trauma surgery, 134(6), 829-834.Doi: 10.1007/s00402-014-1988-6.

Event Description

It was reported that on literature review ¿early postoperative transtibial articular fistula formation after anterior cruciate ligament¿; after surgery with an endobutton, one patient had post-operative subcutaneous fistula and cyst with minor swelling and articular affusion requiring re-operation.

Manufacturer Narrative

H10: 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.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.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.H6: updated codes.

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.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 there was insufficient information to tie the reported complaint to specific line items within the risk file.Our clinical investigation concluded: no conclusions can be made from this publication as its limited to the information provided and further investigation is not possible.Per article ¿all patients wound healing occurred uneventfully without recurrence of the cyst or wound drainage.¿ in addition, the physician referenced in the abstract provided an analysis of all of the attached images.Therefore, no further interpretation of the attached images are required.No further medical assessment is warranted at this time.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: UNKNOWN ENDOBUTTON DEVICE
• 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: 12471546
• MDR Text Key: 271455954
• Report Number: 1219602-2021-02008
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K980155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female