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

Model Number	M656G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Device not returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Could you please confirm if wound dehiscence was noticed? all answers are unattainable additional information requested.Were there any treatments given to the patient were prescribed? was any surgical intervention performed specially re-suturing? explain.
Event or Problem Description
It was reported that a patient underwent an open reduction and internal fixation for comminuted fracture of left patella procedure on (b)(6) 2018 and suture was used.The patient recovered well.Then rehabilitation exercise was recommended.On (b)(6) 2018 at the time of reexamination, a strand of suture was found broken.The patient was advised to reduce the intensity of rehabilitation exercise.When the fracture healed, the surgery of removal of internal fixation device for left patella fracture was performed on (b)(6) 2020.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/22/2021.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.

• Brand Name: STLESS STEEL SIL 2X18IN 5 S/A V-40
• Common Device Name: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11030803
• Report Number: 2210968-2020-10049
• Device Sequence Number: 19704679
• 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,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: M656G
• Device Catalogue Number: M656G
• Device Lot Number: LCJ657
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/22/2021
• Patient Sequence Number: 1