MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT 5CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Model Number	07.704.005S
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: 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 history: part number: 07.704.005s - norian drillable inject 5cc - sterile, lot number: ds7002764 (sterile), lot quantity: 201, manufacturing location: (b)(4).Inspection and release by: monument.Release to warehouse date: 21-jun-2019, expiration date: 28-jun-2020.Purchased finished goods traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Certificate of conformance supplied by dsm dated 17-jun-2019 was reviewed and determined to be conforming.Certificate of conformance sterility parameters were reviewed and determined to be conforming.Nr-0125104 was initiated against this lot due to a power failure that occurred during the preconditioning phase of manufacture.The disposition of the nr was ¿use as is¿ because of the battery back-up system that deployed.The outage did not compromise the efficacy or validation parameters of the product.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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, a norian drillable inject 5cc was not able to mix properly.It did not turn into paste even using the normal technique and procedure followed, so it would not exclude into the syringe, the 5cc norian as discarded and the second box of 3cc norian was mixed successfully and insert into the patient¿s femoral head by the surgeon.Patient status was unknown.This is report 1 of 1 for (b)(4).

• Brand Name: NORIAN DRILLABLE INJECT 5CC-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: 9911394
• Report Number: 2939274-2020-01656
• Device Sequence Number: 3423401
• Product Code: MQV
• UDI-Device Identifier: 10886982131614
• UDI-Public: (01)10886982131614
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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 Expiration Date: 06/28/2020
• Device Model Number: 07.704.005S
• Device Catalogue Number: 07.704.005S
• Device Lot Number: DS7002764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1
• Patient Age: 78 YR