MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 2X18IN 5 S/A V-40; SUTURE, NONABSORBABLE, STEEL

Catalog Number	M656G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 component code: g07002 device not returned.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's weight, bmi at the time of index procedure.What was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? were there any patient stress factors that precipitated the event of suture breakage post op? please describe the surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name?.
Event or Problem Description
It was reported that a patient suffered a right patellar fracture due to a fall injury and underwent an open reduction and internal fixation of right patellar fracture under general anesthesia on (b)(6) 2024 and suture was used.Prior to the surgery, the patient was informed that the right knee joint should not be excessively flexed or moved, and that crutches should be used when moving on the ground to maintain an extended position of the right knee joint.The right thigh should not be subjected to force movements.The patient may have misunderstood postoperative activities, and may not be accustomed to using the restroom in bed.When using the restroom on the ground, they may have a partner in their 70s supporting them.As a result, it is impossible to ensure that their right thigh does not exert excessive force during activities, leading to premature and excessive movement.On the afternoon of the 5th day after surgery, the patient felt a popping sound in the right knee joint accompanied by pain.On the 6th day after surgery, a follow-up x-ray was issued.Due to weather conditions, the patient took a x-ray before the 7th day after surgery, which showed that the tension band steel wire (suture) of the right patella had broken, resulting in the displacement of the kirschner wire and fracture.Conservative treatment was not possible, and surgery was scheduled again.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested but unavailable: please provide the patient's weight, bmi at the time of index procedure.What was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? were there any patient stress factors that precipitated the event of suture breakage post op? please describe the surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name?.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: after investigation, the hospital fed back that the suture involved was used for patellar fixation.The patient had completed the second surgery, and was discharged in stable condition currently.No subsequent adverse event report was received.

• Brand Name: STLESS STEEL SIL 2X18IN 5 S/A V-40
• Common Device Name: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19538892
• Report Number: 2210968-2024-06255
• Device Sequence Number: 17662604
• Product Code: GAQ
• UDI-Device Identifier: 10705031045507
• UDI-Public: 10705031045507
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M656G
• Device Lot Number: SEBJQU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 06/17/2024; 07/12/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 06/25/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male