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

Model Number	PDP880G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.To date it has been reported that the device will not be 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 abdominal hysterectomy, bilateral salpingo-oophorectomy and cystoscopy on (b)(6) 2020 and suture was used.Upon completion of the surgery and closing the incision, the tip of the needle broke off in the patient.The tip was not located, but the wound was irrigated.No x-ray was taken.There were no adverse patient consequences.Additional information will be requested.
Additional Manufacturer Narrative
Date sent to the fda: 01/08/2021.Additional h-3 summary: three pictures were received for evaluation.Upon to visual inspection of the pictures, a a sealed foil packet and a box of product code pdp880g, lot # qamhsc could be observed, however no needles breakage were noted in the pictures.No conclusion could be reached as on what caused the reported complaint, since the sample was not returned for analysis.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.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/05/2021.Additional information was requested and the following was obtained: it was reported that ¿the tip of the 1 pds looped suture broke off in the patient¿.Does it mean a tip of the needle broke? please clarify.Tip - the point used to insert for suturing was gone - either broke or dulled from use.What size of the needle was used? 4.0 metric tp-1.What tissue was being sutured when the event occurred? occurred at end of procedure, closure of the abdomen.Size of the needle piece retained? unknown.What tissue structure is it located? unknown.Was there a reason that x-ray was not performed to locate a needle piece? no.If retained, what is the surgeon's opinion of consequences to the patient? unknown.Was there any change in the patient¿s post-operative care due to this event? no.Are any plans in place to remove the needle piece in future? no, very minute.What is a current condition of the patient? unknown.It was reported that ¿pictures are representation of what was used¿.Do you plan to send us photos? photos upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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: PDS PLUS 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
• MDR Report Key: 10938036
• Report Number: 2210968-2020-09526
• Device Sequence Number: 19641967
• Product Code: NEW
• UDI-Device Identifier: 10705031048669
• UDI-Public: 10705031048669
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020

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: 12/31/2021
• Device Model Number: PDP880G
• Device Catalogue Number: PDP880G
• Device Lot Number: QAMHSC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 01/07/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/05/2021; 01/08/2021
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 53