MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 4-0 S/A PC-5 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8631G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.
Event or Problem Description
It was reported that a patient underwent a carpal tunnel repair procedure on (b)(6) 2019 and suture was used.The needle detached from the thread at the swage during closure of the skin.Another like device was used to complete the skin closure successfully with no delay.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device batch mmh267 and no non-conformances were identified.The actual device was received for analysis a labeled winding former with a detached needle of product code 8631, mmh267.During the visual inspection of a detached needle, the swage and attachment area were noted to be as expected.Body fluids was present on needle and marks by use of a surgical instrument could be observed at the edge of the barrel hole, this condition causes the needle pull off.The suture was not received for evaluation.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, the assignable cause of the performance pull off - suture needle is an improper handling.Representative samples of an opened box with ten unopened samples of product code 8631, mmh267.During the visual inspection of ten unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the sample received, no performance pull off suture needle was found, and the tested sample met the finished goods requirements.

• Brand Name: PRLNE BLU 18IN 4-0 S/A PC-5 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9287777
• Report Number: 2210968-2019-89636
• Device Sequence Number: 13984808
• Product Code: GAW
• UDI-Device Identifier: 10705031018105
• UDI-Public: 10705031018105
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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 Catalogue Number: 8631G
• Device Lot Number: MMH267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/11/2019
• Patient Sequence Number: 1