MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A BV175-8 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8745
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2020
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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Could you please explain what do you mean by "the suture is breaking off the needle"?.
Event or Problem Description
It was reported that a patient underwent an unknown surgery procedure on (b)(6) 2020 and suture was used.During the procedure, the suture was detached from the needle.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 09/28/2020.A manufacturing record evaluation was performed for the finished device pmp990 batch number, and no non-conformances were identified additional h3 investigation summary :it was reported performance pull off - suture needle.It was received for analysis an unopened sample of product code m8745, lot pmp990.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problem and examined along of the strand and no defects 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 condition of the sample, no performance pull off - suture needle was found, and the tested sample met the finished goods requirements.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 inc 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.

• Brand Name: PRLNE BLU 4X24IN 7-0 D/A BV175-8 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: 10423697
• Report Number: 2210968-2020-06196
• Device Sequence Number: 2961202
• Product Code: GAW
• UDI-Device Identifier: 10705031046078
• UDI-Public: 10705031046078
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 10/31/2024
• Device Model Number: M8745
• Device Catalogue Number: M8745
• Device Lot Number: PMP990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/28/2020
• Patient Sequence Number: 1