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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2021

Event Type  malfunction  

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 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).

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
• Type of Device: 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
• MDR Text Key: 265588789
• Report Number: 2939274-2021-04259
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 20886982000306
• UDI-Public: (01)20886982000306
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/03/2021
• Patient Sequence Number: 1
• Treatment: NORIAN DRILLABLE INJECT 5CC-STERILE