MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 03.804.517S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.

Event Description

It was reported that on (b)(6) 2021, during a vertebroplasty procedure, while using the confidence needles with a patient who has very hard bone making it difficult to insert the needle, a larger diamond access kit 10 gauge was used.Towards the end of the procedure during the removal of the confidence needle (on the left side), it became difficult to remove and the handle broke off.The diamond needle on the right side had already been removed and they were working on the left with the cannula on the right side with the broken handle.The needle remained in the vertebral body.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.This report is for one (1) access kit 10 gauge-diamond tip/end-opening-sterile.This is report 1 of 1 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.H10 additional narrative: h3, h4, h6: part: 03.804.517s.Lot: 20f15-1.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: july 2, 2020.Expiry date: june 15, 2025.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.G1: manufacturing site name and address.

• Brand Name: ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILE
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11995591
• MDR Text Key: 264935501
• Report Number: 2939274-2021-02941
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705034722641
• UDI-Public: 10705034722641
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.804.517S
• Device Catalogue Number: 03.804.517S
• Device Lot Number: 20F15-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR