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	Chemical Problem (2893)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This patient¿s information is unknown.Implanted, explanted dates: due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).A device history record (dhr) review was conducted for part # 07.704.010s, lot: dse6844: qty rec'd: (b)(4), rec'd date: 29 nov 2017, manufacturer: dsm biomedical - (b)(6) in (b)(6): product was inspected and passed per certificate of conformance received from dsm biomedical inc, certifying that the product was manufactured in accordance to the material and customer/industry specifications noted on the product drawing and purchase order.There were no ncs or reworks generated during the manufacturing of the product.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that 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.
Event or Problem Description
It was reported that during an open reduction internal fixation (orif) of a tibia fracture on (b)(6) 2018, a syringe did not lock properly to the pouch of a norian drillable inject causing the solution to leak.The pouch could not be used for the procedure.The surgeon used another norian drillable inject to complete the procedure.There was no surgical delay.Surgery was successfully completed.The patient outcome reported as stable.This is report 1 of 1 for complaint (b)(4).

• 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: 7675578
• Report Number: 2939274-2018-52789
• Device Sequence Number: 1577937
• Product Code: MQV
• UDI-Device Identifier: 10886982131621
• UDI-Public: (01)10886982131621
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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: 06/28/2019
• Device Model Number: 07.704.010S
• Device Catalogue Number: 07.704.010S
• Device Lot Number: DSE6844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/10/2018
• Patient Sequence Number: 1
• Patient Age: 66 YR