MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

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

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Deformity/ Disfigurement (2360); Skin Inflammation/ Irritation (4545)

Event Date 04/20/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Citation: zhongguo gu shang/china j orthop trauma,2014,27(10):809-814 ; (b)(6).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: titanium elastic nail versus plate-screw fixation for the treatment of upper segment fractures of femoral shaft in children this prospective study aimed to compare the complications and clinical outcome of titanium elastic nail (ten) versus plate-screw fixation (pf) for the treatment of upper segment fractures of femoral shaft in children.From january 2006 to august 2012, 32 children ages 3-12 years old with middle and upper segment femoral fractures were randomly selected for treatment with titanium elastic nail (ten) and plate-screw fixation (pf).Ninteen patients were treated with titanic elastic nail (ten) fixation including 11 males and 8 females with an average age of (6.9 ± 2.2) years old ranging from 3 to 11, 11 cases of them were type a, 6 cases were type b,2 cases were type c according to ao classification.The other 13 patients were treated with plate-screw fixation (pf) including 9 males and 4 females with an average age of (7.5 ± 2.1) years old ranging from 5 to 12 years, and 3 cases of them were type a,6 cases were type b,2 cases were type c.Skin was sutured with absorbable suture (produced by johnson & johnson, usa) for both groups.Operative time, blood loss,incision length,the time of hospitalization,fracture healing time, postoperative complications and function recovery between two groups were compared and evaluated.Reported complications in the titanium elastic nail (ten) group included superficial infection of incision (n=1), nail tail irritation (n=2), limb length inequality (n=3), angulation deformity (n=1), pain at the site of nail tail implantation (n=2), fever (n=?) and rotational deformity (n=1).Reported complications in the plate-screw fixation (pf) group included limb length inequality (n=2) and fever (n=?).Antibiotics were given intravenously 30 minutes before the operation and 1-3 days after the operation to prevent infection, and the patients with a fever were treated with anti-infection therapy.Superficial infection was cured after dressing change, nail tail irritation was cured when the internal fixation was removed after fracture healing and pain disappeared after removing the intramedullary nail.All the patients were followed up after the operation.The follow-up time of the titanium elastic nail group was 15 - 48 months, with an average of 25.3 months; the follow-up time of the plate-screw fixation group was 13 - 36 months, with an average of 21.6 months.There was no significant difference in the operation time, duration of hospital stay, removal time of internal fixation or fracture healing time between the titanium elastic nail group and the plate-screw fixation group (p > 0.05), but there were significant differences in the intraoperative blood loss and the incision length between the two groups (p < 0.05).There was no statistically difference in postoperative in complication between two groups, but the patients in ten group had a higher incidence of soft tissue irritation and misalignment.Outcome scores according to sanders had no significant difference between two groups (p>0.05).In ten group,the result was excellent in 13 cases, good in 3,fair in 2, and poor in 1, while in pf group excellent in 10, good in 2, fair in 1.In conclusion, with titanium elastic nail and plate-screw fixation, good bone healing and functional recovery in the treatment of children with middle and upper segment femoral fractures can be achieved, and both methods have their own advantages.The surgical treatment should be based on the children¿s age, weight, the wishes of the children¿s family members, the scar size, the fracture stability, the degree of comminution, the distance between the fracture and the trochanter, complications and other factors after comprehensive analysis.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11732409
• MDR Text Key: 247520546
• Report Number: 2210968-2021-03832
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention