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
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.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
It was reported that on (b)(6) 2020, during an unknown procedure, the norian drillable inject 10cc failed to mix in the unknown rotary mixer and all the sodium hyaluronate was ejected from the norian pouch during mixing.When the surgeon tried using the norian drillable fast set putty 5cc, it hardened immediately within ten (10) seconds of getting it mixed.So, the surgeon tried again of 5cc of unknown drillable inject and it worked well.The procedure was completed successfully with a surgical delay of two (2) minutes.The patient outcome was unknown.Concomitant device reported: unknown rotary mixer (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This report is for (1) norian drillable inject 10cc-sterile.This report is 1 of 2 for (b)(6).

• Brand Name: NORIAN DRILLABLE INJECT 10CC-STERILE
• Common Device Name: 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: 10985217
• Report Number: 2939274-2020-05544
• Device Sequence Number: 4295114
• Product Code: MQV
• UDI-Device Identifier: 10886982131621
• UDI-Public: (01)10886982131621
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102722
• 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
• Report Date (Section B): 11/15/2020

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 Model Number: 07.704.010S
• Device Catalogue Number: 07.704.010S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2020
• Initial Report FDA Received Date: 12/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NORIAN DRILLABLE FAST SET PUTTY 5CC-STERILE; UNK - MIXERS