Suture, Absorbable, Synthetic

Description of Event or Problem

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The needle pulled off. The operating room staff had to provide four additional sutures to complete the suturing. No adverse patient consequences were reported. Additional information was requested

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (b)(4).D4/G4: Device is not distributed in the United States but is similar to device marketed in the USA. Therefore, (01)GTIN is not available.Attempts have been made to retrieve the device. 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.Additional information was requested, and the following was obtained:¿ Did this issue contribute to any patient adverse event? no consequence for the patient but 4 wires used for nothingAttempts 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.¿ When was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? Please specify¿ How many needles detached from the suture thread during use on the patient?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, or its employees that the report constitutes an admission that the product, Ethicon, 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.