MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT 10CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Model Number 07.704.010S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Additional 510k: k073303.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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 during a tarsometatarsal (tmt) foot fusion on (b)(6) 2018, the nurse was about to mix the norian and removed the cap on the liquid part of the syringe when the lock came off and prevented the liquid from mixing into the powder packet.Another norian pack was used, but the surgeon had to lower the patient¿s tourniquet then raise it back up and start over.This resulted in a ten (10) minute surgical delay.No patient harm.Procedure complete successfully.Patient outcome is stable.This complaint involves one (1) device.This report 1 of 1 (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Dhr review was completed.Part number: 07.704.010s , synthes lot number: dsd7643 , supplier lot number: n/a , release to warehouse date: 15-dec-2016 , expiration date: 28-feb-2018 , supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.The item was forwarded to dsm and the concluded: complaint (b)(4) was reviewed and closed on february 22, 2018.A review of dhf norian fiber reinforced rotary pouch, 80030-03, d7643, and filled syringes for norian fiber reinforced rotary pouch, 6839-03, d0501 was completed and the product met all acceptance criteria for commercial release.The dhf review included all incoming, in-process, and final inspections, specifications, and manufacturing processes.No deviations or ncr's were issued during the manufacturing of the products related to this complaint.Root cause could not be confirmed.All applicable device history files and risk assessments were reviewed, and no discrepancies applicable to this complaint were noted.It has been determined that there is no assignable cause to the device, as the device history file review showed no discrepancies occurred during the manufacturing of this lot; however, the likely cause for this complaint is determined to be end user error.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not 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: NORIAN DRILLABLE INJECT 10CC-STERILE
• Type of Device: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7249692
• MDR Text Key: 99802682
• Report Number: 2939274-2018-50541
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 10886982131621
• UDI-Public: (01)10886982131621(17)20190228(10)DSD7643
• Combination Product (y/n): N
• PMA/PMN Number: K102722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 07.704.010S
• Device Catalogue Number: 07.704.010S
• Device Lot Number: DSD7643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Date Manufacturer Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR