MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 27IN 4-0 S/A FS-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z422H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an unknown orthopedic surgery on (b)(6) 2021 and the suture was used.Intra-op, the suture had been broken.The operation time was extended within 30 minutes.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot number qbzaqz and no non-conformance's related to the reported complaint condition were identified.Additional information was requested, and the following was obtained: please provide status of product return? the device will be shipped.No further information will be provided.The following information was requested, but unavailable: how was procedure successfully completed? when did the suture broke, before use on patient (pre-op), during use on patient (intra-op)or after use on patient (post-op).Was there any change in the patient¿s post-operative care due to the prolonged procedure? the product upon which this medwatch is based has been received, however, at time of submission, evaluation not yet in complete status and therefore not reported in the initial medwatch.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/15/2021.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, 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.H3 evaluation: visual analysis of the returned product revealed that one opened sample product code z422 was received for evaluation.Upon visual inspection of the returned sample, the suture was received cutted in two pieces.After further evaluation crimping marks were observed on the surface and the ends suture possibly from a surgical instrument.The product code z422 contains absorbable suture, as the sample was received open, the time of exposed to the environment could not be determined and functional test cannot be performed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.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.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: PDSII CLR 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12804813
• Report Number: 2210968-2021-11367
• Device Sequence Number: 5485163
• Product Code: NEW
• UDI-Device Identifier: 10705031060890
• UDI-Public: 10705031060890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 01/31/2025
• Device Model Number: Z422H
• Device Catalogue Number: Z422H
• Device Lot Number: QBZAQZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown