MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 6-0 S/A PC-1 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y833G
Medical Device Problem Codes	Degraded (1153); Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device hmk785 number, and no non-conformance's were identified.Three empty opened foils, three paper lid, an empty winding former, three sutures inside winding former and a detached needle of product code (b)(4), lot hmk785 were returned for analysis.During the visual inspection of the detached needle, the swage and attachment area the swage and attachment area were noted to be as expected and a suture piece still was attached to barrel needle.Three winding formers were visually examined, and the sutures could not be dispensed since have begun with the process of degradation and this condition caused that the suture detached from the needle.The time of exposure of sutures to the environment could not be determined.Also, the foils were examined and showed multiples wrinkles and holes in cavity on bottom foil packages due to excessive manipulation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, the assignable cause is suture degradation due to the improper handling of package.Note: reportable events were submitted via 2210968-2019-80629, 2210968-2019-80630, 2210968-2019-80631.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.After taking the suture in the hand, the suture got detached from the needle.Upon evaluation of the device, the suture could not be dispensed as it has begun the process of degradation.The foils were examined and showed multiple wrinkles and holes in cavity on bottom foil packages due to excessive manipulation.There were no adverse patient consequences reported.

• Brand Name: MCRYL UD 18IN 6-0 S/A PC-1 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8541667
• Report Number: 2210968-2019-80631
• Device Sequence Number: 367727
• Product Code: GAN
• UDI-Device Identifier: 10705031059672
• UDI-Public: 10705031059672
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K964072
• 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
• Report Date (Section B): 03/26/2019

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 Expiration Date: 07/31/2019
• Device Catalogue Number: Y833G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1