MAUDE Adverse Event Report: ETHICON INC. PDS SUTURE 18"(45CM) 4-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D8252
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 a patient underwent a bone grafting procedure on (b)(6) 2018 and a suture was used.During surgery, it was found that the needle had been unusually bent when opening the package.The needle was broken at the middle when the surgeon tried to fix it.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.The reported event is not malfunction reportable.Therefore, this medwatch report is not reportable.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/26/2018.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary: it was reported - bending needle.A failed suture needle, was submitted for fractographic evaluation.The component was identified as product code d8252.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.This was a ductile fracture.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The evidence of this examination indicates that the breakage occurred from mechanical deformation, indents and scratches, due to gripping, bending and overstressing of the needle.  there is no evidence of any material flaw that would cause premature failure.The sample was received for analysis due to bending needle.A needle piece, a needle-suture piece and a suture piece of product code d8252, lot mem493 were returned for evaluation.During the visual inspection of the sample, the needle was breaking in two sections and no bending needle were noted; however, the curve does not conform to the needle specification; since, the tangent was straight resulting in an incorrect curve.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, no performance bending needle was observed; however, an incorrect curvature was found.
Event or Problem Description
It was reported that a patient underwent a bone grafting procedure on (b)(6) 2018 and a suture was used.During surgery, it was found that the needle had been unusually bent when opening the package.The needle was broken at the middle when the surgeon tried to fix it.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: PDS SUTURE 18"(45CM) 4-0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7905436
• Report Number: 2210968-2018-75958
• Device Sequence Number: 1683026
• Product Code: NEW
• UDI-Device Identifier: 10705031029644
• UDI-Public: 10705031029644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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,Followup
• Report Date (Section B): 11/29/2018

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: 04/30/2023
• Device Catalogue Number: D8252
• Device Lot Number: MEM493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 08/31/2018; 11/29/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/10/2018; 12/28/2018
• Patient Sequence Number: 1