MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DELIVERY NEEDLE 10GA X 10CM-STERILE-5PK; NEEDLE, ASPIRATION AND INJECTI ON, DISPOSABLE

Model Number	DLS-7103-05S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Occupation: reporter is a j&j sales representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Was reported that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, the liquid from norian drillable inject leaked out from connection to powder packet when injected.There was no surgical delay.The procedure outcome is unknown.No patient consequence.This complaint involves two (2) devices.This report is for (1) delivery needle 10ga x 10cm-sterile-5pk.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part #: dls-7103-05s, synthes lot #: dse6925, supplier lot #: dse6925, release to warehouse date: 01 feb 2018, expiration date: 28 jul 2022, supplier: (b)(4), no ncr's generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DELIVERY NEEDLE 10GA X 10CM-STERILE-5PK
• Common Device Name: NEEDLE, ASPIRATION AND INJECTI ON, DISPOSABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12220706
• Report Number: 2939274-2021-04259
• Device Sequence Number: 3635426
• Product Code: GAA
• UDI-Device Identifier: 20886982000306
• UDI-Public: (01)20886982000306
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2021

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: 07/28/2022
• Device Model Number: DLS-7103-05S
• Device Catalogue Number: DLS-7103-05S
• Device Lot Number: DSE6925
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/24/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NORIAN DRILLABLE INJECT 5CC-STERILE