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	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.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) 2018, the patient underwent an unknown surgery for proximal tibial fracture.During the procedure, the norian drillable inject was not mixed properly in the mixing machine and was not delivered into the syringe as intended.The norian drillable packaging appeared to be the issue and not the mixing machine.Another box was used.The procedure was successfully completed with no delay reported.The patient was stable throughout the surgery.Concomitant device reported: mixing machine (part: mxr-ux-2000, lot: unknown, quantity: 1).This report is for norian drillable inject 5cc-sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device history record (ddhr) review: part number: 07.704.005s, - norian drillable inject 5cc - sterile; lot #: ds7000213 (sterile); lot quantity 274; manufacturing location: (b)(4) release to warehouse date: march 13, 2018; expiration date: november 28, 2019; inspection sheet for incoming final inspection met inspection acceptance criteria.Certificate of conformance received from dsm dated march 08, 2018 was reviewed and found to be conforming.Certificate of conformance sterility documentation was reviewed and determined to be conforming.This lot met all visual, sterilization and packaging criteria at the time of release with no issues documented that would contribute to this complaint condition.Investigation summary: the implant was received with the reported condition of ¿functional cement will not mix properly : rm¿.The following investigation flow were performed: device interaction/functional.It was visually observed that there is cement in the delivery syringe and has hardened.No evidence of cement elsewhere on the delivery system.The complaint was not able to be replicated because a functional test could not be completed as the cement has already hardened with in the rotary pouch.The received condition does agree with the complaint description.The complaint is confirmed.Dimensional analysis is not applicable due to the returned condition of the product, hardened cement within the pouch.A device history review, was performed for the returned implant¿s lot number and no manufacturer review records (mrrs), nonconformance records (ncrs) or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.A review of the current design drawing and the drawing revision at the time of manufacture was performed: top level and no issues were identified.While no definitive root cause could be determined it is likely that the cement was not implanted within the 5-minute maximum time frame refenced in the relevant technique guide (norian drillable inject surgical technique, dsus/moc/0914/0104 12/16) on page 8 which lead to the mixing issues noted in the complaint description.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
Additional 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.Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 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: 7689624
• Report Number: 2939274-2018-52885
• Device Sequence Number: 10989511
• Product Code: MQV
• UDI-Device Identifier: 10886982131614
• UDI-Public: (01)10886982131614
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2018

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: 11/28/2019
• Device Model Number: 07.704.005S
• Device Catalogue Number: 07.704.005S
• Device Lot Number: DS700213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 07/25/2018; 08/10/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/02/2018; 08/15/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2018; THERAPY DATE: (B)(6) 2018