MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT 5CC-STERILE; MANDIBULAR CONDYLE PROSTHESIS

Model Number 07.704.005S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Implant date and explant date is not applicable as product was not utilized.A device history record review was requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.(b)(4).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 Description

It was reported that during an open reduction internal fixation (orif) of the of tibial plateau on (b)(6) 2018.The 5 cc norian drillable inject was finished mixing using the rotary mixer and it would not transfer into the delivery syringe.There was a surgical delay of 2 minutes.The surgery was completed successfully using the 3 cc norian.There was no patient consequence reported.This is report 1 of 1 for (b)(4).

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.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 Description

Concomitant devices reported: rotary mixer (part number unknown, lot number unknown, quantity 1); cement delivery syringe (part number unknown, lot number unknown, quantity 1).

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.Device history record (dhr) review: item: 07.704.005s; dsm item: 80030-02; lot: dse8240; qty rcv'd: 200; rcv'd date: 26 jan 2018; manufacturer: dsm bimedical - kensey nash; exp date: 28 sep 2019.Review of dhr found incoming final inspection was performed and passed all inspection criteria per inspection sheet.Certificate of conformance provided by dsm biomedical inc., certifying that product was manufacturing to current device drawing.There were no nonconformance records (ncrs) or reworks initiated during the production of this product.No ncrs were generated during production.Review of the device history record showed there were no issues during the manufacture of the product that would contribute to this complaint condition.Investigation summary: flow: device interaction/functional.Visual inspection - the norian drillable (part 07.704.005s, lot dse8240, release to warehouse: 26 jan 2018) was received at us customer quality (cq) with cement present in the rotary pouch.There is no cement present in the delivery syringe however there is cement in the pouch at the interface with the syringe.Additionally, the glass syringe component for sodium hyaluronate solution was returned empty.Functional test - the complaint was not able to be replicated because a functional test could not be completed as the cement has already hardened within the rotary pouch.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection - dimensional analysis is not applicable due to the returned condition of the product, hardened cement within the pouch.Document/specification review - the device drawing(s) was reviewed.Dhr review showed no ncr¿s were generated during production.Conclusion - the complaint condition is confirmed as the norian drillable (part 07.704.005s, lot dse8240) was received with cement hardened within the pouch.There is no indication that a design or manufacturing issue contributed to the complaint.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.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.

• Brand Name: NORIAN DRILLABLE INJECT 5CC-STERILE
• Type of Device: MANDIBULAR CONDYLE PROSTHESIS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7595949
• MDR Text Key: 110879860
• Report Number: 2939274-2018-52485
• Device Sequence Number: 1
• Product Code: MOV
• UDI-Device Identifier: 10886982131614
• UDI-Public: (01)10886982131614
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 07.704.005S
• Device Catalogue Number: 07.704.005S
• Device Lot Number: DSE8240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Date Manufacturer Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THERAPY DATE: (B)(6) 2018.
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 127