MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN

Model Number	C003D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a hartmann's procedure on (b)(6) 2021 and suture was used.During the procedure, a needle was found in the operative field.At that time, c003d had been used for suture ligature.It is unknown when the needle left in the operative field fell out, and neither the doctor nor nurse confirmed that the needle dropped out while using c003d.It was also unknown whether the needle left in the operative field was c003d.The needle that had dropped in the operative field was retrieved, and the operation was continued.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).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 batch qpbaxr, and no non-conformances were identified.(b)(4).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: could you please clarify, what do you mean by ""sh-1 needle""? sh-1 is name of the needle.Could you please confirm if it was used another package apart from the two c003d packages mention in event description? z771d also used.It was possible that one device will be pull off and as a result leave the needle in the surgery field? if yes please confirm.No further information is available.It was possible that needle was breakage? if yes please confirm.No further information is available.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.The event was reported that 1 needle from product code c003d pulled off during the hartmann¿s procedure on (b)(6) 2021.Could you please confirm that only 1 needle c003d pulled off during suturing on this patient on the (b)(6) 2021 hartmann¿s procedure? is this correct? it was stated in the additional information that a device from product code z7712 was used.Was there any issue with the device from product code z7712? please explain.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/13/2021.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 h3 investigation summary: visual analysis of the returned sample determined that two empty winding formers and seventeen used needles needle product code c003d were received to ethicon inc for evaluation.The product code is single-armed, control release and each tray contains eight strands.As per visual inspection of the needles, the swage and attachment area were noted to be as expected, marks by the surgical instrument were noted on body needle and no suture remnant could be observed into the barrel hole.The sutures were not received for evaluation.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.Additional information was requested and the following was obtained: the event was reported that 1 needle from product code c003d pulled off during the hartmann¿s procedure on (b)(6) 2021.Could you please confirm that only 1 needle c003d pulled off during suturing on this patient on the (b)(6) 2021 hartmann¿s procedure? is this correct? no further information is available.It was stated in the additional information that a device from product code z7712 was used.Was there any issue with the device from product code z7712? please explain: z7712 was also used in the surgery.But it is unknown which product the needle that had fallen belongs to.No further information will be provided.(b)(4).Date sent to the fda: 10/13/2021.Corrected information: d4, h4 - the actual product code and device batch number associated with this event is not known.The international affiliate reports the following possible product code and batch numbers: product code c003d, batch qpbaxr mfg date: 12/4/2020, exp date: 11/30/2025.Product code z7712, batch unknown mfg date: unknown, exp date: unknown.In addition, a review of the batch manufacturing records for the possible batch number qpbaxr was conducted and the batches met all finished goods release criteria.

• Brand Name: SUTURE UNKNOWN
• Common Device Name: SUTURE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12515549
• Report Number: 2210968-2021-08759
• Device Sequence Number: 3585743
• Product Code: GAK
• UDI-Device Identifier: 10705031023345
• UDI-Public: 10705031023345
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 11/30/2025
• Device Model Number: C003D
• Device Catalogue Number: C003D
• Device Lot Number: QPBAXR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/13/2021
• Patient Sequence Number: 1