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

Model 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
Product complaint: (b)(4).A manufacturing record evaluation was performed for the finished device phe760 batch number, and no non-conformances were identified.H-3 summary: it was received for analysis an empty opened overwrap, an empty opened labeled winding former, two needle-sutures pieces and a suture piece of product.During the visual inspection of the opened sample, the swage and attachment area were noted to be as expected.The suture pieces were examined, and present damaged and the ends isn't broken, it's cut appears to be by de use of a surgical instrument.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.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.Reported suture event was submitted via 2210968-2020-06361.
Event or Problem Description
The event was not reported.However, the suture product was received without any details of event.Upon evaluation, the suture observed damaged and possibly cut.

• 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: 10549169
• Report Number: 2210968-2020-07056
• Device Sequence Number: 1217590
• Product Code: GAW
• UDI-Device Identifier: 10705031232754
• UDI-Public: 10705031232754
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 09/02/2020

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: 06/30/2024
• Device Model Number: HS6822H
• Device Catalogue Number: HS6822H
• Device Lot Number: PHE760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1