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

Catalog Number	8697G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch mhp675-8697g and no non-conformances were identified.Attempts are being 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 the patient underwent an unknown dental and oral surgery on (b)(6) 2019 and suture was used.The suture was detached from the needle soon after starting to use.It was not a control release needle.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: it was reported performance pull off -suture needle.It was received for analysis a suture piece of product code 8697g, lot mph675.During the visual inspection of the suture piece, not impression at the swage area and the end was damaged (cut) could be observed.In addition, the needle was not return, and we are unable to determine the assignable cause.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to that the needle was not received, and condition of suture received, it could not be determined what may have caused the reported incident.

• Brand Name: PRLNE BLU 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: 8957934
• Report Number: 2210968-2019-86516
• Device Sequence Number: 14068186
• Product Code: GAW
• UDI-Device Identifier: 10705031019218
• UDI-Public: 10705031019218
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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): 08/08/2019

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: 06/30/2023
• Device Catalogue Number: 8697G
• Device Lot Number: MHP675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1