MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 96IN 1 S/A TP-1 LP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP880G
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).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 total knee replacement procedure in 2018 and a suture was used.During surgery, the needle broke.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/10/2019.Device evaluation summary: a used suture needle was submitted for evaluation.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation 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 at the tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The needle breakage was confirmed.An unopened sample of product code pdp880, lot # mg6385 was returned for analysis.During the visual inspection of an unopened sample, no defects were found on the package.The sample was opened and the swage and attachment area were noted to be as expected; also, the tip and body of the needle were examined and no defects or needle breakage were observed.The suture was dispensed without problems and examined along of the strand and no defect were observed.Also, the sample was tested by resistance test to needle and the needle met the requirements.Per the condition of the representative sample, no performance ¿ breakage needle was found on the sample.

• Brand Name: PDS+ VIO 96IN 1 S/A TP-1 LP
• 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: 8157119
• Report Number: 2210968-2018-77706
• Device Sequence Number: 10824015
• Product Code: NEW
• UDI-Device Identifier: 10705031048669
• UDI-Public: 10705031048669
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: 05/31/2020
• Device Catalogue Number: PDP880G
• Device Lot Number: MG6385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/10/2019
• Patient Sequence Number: 1