MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 36IN 3-0 D/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	HS6822H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 an unknown procedure on an unknown date and suture was used.The suture was broken during suturing.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: concomitant medical products, device manufacture date.Evaluation: one empty labeled winding former and two needle-suture piece of product code hs6822, lot mph335 were received for analysis.The product code is double armed.During the visual inspection of the opened sample (two needle/suture pieces), the swage and attachment area were noted to be as expected.However, marks on the body needle and the end of the suture pieces cut that appears to be by the use of a surgical instrument could be observed.The other section of the suture was not returned for analysis and due to the condition of the sample the functional test can¿t be performed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling and the complaint one empty labeled winding former and two needle-suture piece of product code hs6822, lot mph335 were received for analysis.The product code is double armed.During the visual inspection of the opened sample (two needle/suture pieces), the swage and attachment area were noted to be as expected.However, marks on the body needle and the end of the suture pieces cut that appears to be by the use of a surgical instrument could be observed.The other section of the suture was not returned for analysis and due to the condition of the sample the functional test can¿t be performed.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.

• Brand Name: PRLNE HS BLU 36IN 3-0 D/A SH
• 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: 9363201
• Report Number: 2210968-2019-90209
• Device Sequence Number: 19375021
• Product Code: GAW
• UDI-Device Identifier: 10705031232754
• UDI-Public: 10705031232754
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 11/30/2023
• Device Catalogue Number: HS6822H
• Device Lot Number: MPH335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/30/2019
• Patient Sequence Number: 1