MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 6-0 S/A P-1 PRM; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	697H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional evaluation summary: representative samples were returned for analysis.During the visual inspection of sample, the swage and attachment area were as expected.The suture was dispensed without problems and examined along of the strand and no defects, damaged or suture breakage was observed.The sample was tested by knot tensile strength and the result was above the minimum individual strength requirement.Per the condition of the representative sample, no suture breakage was found on the suture and the tested sample met the finished goods requirements.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and suture was used.It was reported that the suture broke during the procedure.The doctor reported that the suture is very brittle and of very poor quality.No adverse patient outcome was reported.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: lkp660- mfg.Date - 09/12/2017 ; exp.Date - 08/31/2022.Lkh039- mfg.Date - 9/18/2017 ; exp.Date - 8/31/2022.Ljr999 - mfg.Date - 08/05/2017; exp.Date - 07/31/2022.Lmh071- mfg.Date - 11/11/2017 ; exp.Date - 10/31/2022.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.Actual samples were returned for evaluation.During the visual inspection the swage and attachment area were as expected and marks were observed on the body needle.The end of the suture was observed cut appears to be by use of a surgical instrument.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.In addition, the samples were tested by knot tensile strength and the result was above the minimum individual strength requirement.According to the sample condition suggests an improper handling of the sample.

• Brand Name: ETHLN BLK 18IN 6-0 S/A P-1 PRM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7424177
• Report Number: 2210968-2018-72100
• Device Sequence Number: 1051854
• Product Code: GAR
• UDI-Device Identifier: 10705031008557
• UDI-Public: 10705031008557
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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: No Information
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 697H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1