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

Catalog Number 72202595

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

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 09/07/2018

Event Type  Injury  

Event Description

It was reported that a patient was admitted to the hospital because of a right achilles tendon rupture.The surgery was performed on the (b)(6) 2018 under general anesthesia, right ankle rupture anastomosis surgery was made, surgery total time was of 50 minutes, 30 minutes before surgery they gave the patient, cefuroxime sodium 1.5g intravenously, the operation was successful.Routine dressing changed after surgery, surgical incision healed well.Patient was discharged after 8 days.After discharged patient changed medicine by himself.15 days after the operation right lower extremity swollen and pained, dressing was changed in the hospital and patient was treated with antibiotics by intravenous infusion, surgical incision healed well and suture was successfully removed.40 days after operation patient reported exudation in original incision, dressing was changed at local hospital.On the (b)(6) 2018 there was no improvement so the patient was re-admitted to hospital because of infection, after the admission they change the drug, treat patient with intravenous antibiotics again and also with symptomatic treatment, a bacterial culture was made.

Manufacturer Narrative

Examination is not possible, as the device has not been returned.Based on the nature of the complaint, a review of the sterility records was conducted.The product was sterilized per specifications.All process parameters were confirmed to be within specification.A review of the manufacturing records was performed which confirmed no abnormalities were reported with this lot during manufacture.A complaint history review identified no additional complaints for this manufactured lot.

Event Description

It was reported that a patient was admitted to the hospital because of a right achilles tendon rupture.The surgery was performed on the (b)(6) 2018 under general anesthesia, right ankle rupture anastomosis surgery was made and last a total of 50 minutes.30 minutes before surgery they gave the patient, cefuroxime sodium 1.5g intravenously and the operation was successful.Routine dressing was changed after surgery and the surgical incision healed well.Patient was discharged after 8 days.After discharged, patient changed medicine by himself.15 days after the operation, the right lower extremity swollen and pained; therefore, the dressing was changed in the hospital and patient was treated with antibiotics by intravenous infusion.The surgical incision healed well and suture was successfully removed.40 days after operation patient reported exudation in original incision and dressing was changed at local hospital.On the (b)(6) 2018 there was no improvement so the patient was re-admitted to the hospital because of infection.After the admission, they changed the drug, treated patient with intravenous antibiotics again and also with symptomatic treatment and a bacterial culture was made.

• 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 boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8405597
• MDR Text Key: 138350333
• Report Number: 1219602-2019-00286
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2023
• Device Catalogue Number: 72202595
• Device Lot Number: 50710597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• 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): Hospitalization
• Patient Age: 33 YR