MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202595

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

Patient Problem Wound Dehiscence (1154)

Event Date 08/24/2021

Event Type  Injury  

Event Description

It was reported that, after a left achilles tendon surgery had been performed on (b)(6) 2021 with a twinfix, the patient experienced a wound crack and the achilles tendon was exposed after suture removal.This adverse event was treated with outpatient treatment; however, the wound did not improve.The patient was hospitalized for post-operative debridement and vacuum scaling drainage and the wound healed.The patient current health status is normal.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Internal complaint reference (b)(4).H10 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.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 the reported failure was documented appropriately.A review found no prior escalation actions related to this failure.This adverse event occurred after surgery and it was reported the twinfix did not malfunction.Based on the information provided, ¿the wound crack was may have been caused by the patient's poor healing ability at his age, or intraoperative soft tissue protection, or failure to wear a brace throughout the postoperative period.¿ reportedly, this adverse event was treated with outpatient treatment; however, the wound did not improve.Consequently, the patient was hospitalized for post-operative debridement and vacuum scaling drainage and the wound healed and the patient¿s current health status is normal.Therefore, no further clinical/medical assessment is warranted at this time.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.Procedural variances may affect patient outcomes.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

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.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 the reported failure was documented appropriately.A review found no prior escalation actions related to this failure.This adverse event occurred after surgery and it was reported the twinfix did not malfunction.Based on the information provided, ¿the wound crack was may have been caused by the patient's poor healing ability at his age, or intraoperative soft tissue protection, or failure to wear a brace throughout the postoperative period.¿ reportedly, this adverse event was treated with outpatient treatment; however, the wound did not improve.Consequently, the patient was hospitalized for post-operative debridement and vacuum scaling drainage and the wound healed and the patient¿s current health status is normal.Therefore, no further clinical/medical assessment is warranted at this time.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.Procedural variances may affect patient outcomes.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: TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &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: 12788798
• MDR Text Key: 280598769
• Report Number: 1219602-2021-02485
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010647467
• UDI-Public: 03596010647467
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093228
• 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,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72202595
• Device Catalogue Number: 72202595
• Device Lot Number: 2049798
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2020
• 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 Sex: Male