MAUDE Adverse Event Report: SYNTHES GMBH NORIAN DRILLABLE INJECT 5CC-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Model Number 07.704.005S

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 Description

It was reported that on an unknown date the surgeon requested to use 5cc of norian.As the circulating nurse was preparing the bone void filler by twisting the solution syringe into the injectable port.The port cracked and the solution leaked as it was inserted.No paste was created or used.There was no surgical delay and no patient outcome.This report is for one (1) norian drillable inject 5cc-sterile.This is report 1 of 1 for complaint (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.H3, h4, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the norian drillable inject 5cc-sterile had the injection port cracked.The device was received in its original but opened package, the syringe was not returned for evaluation.It was determined that cracking in the luer lock components of the rotary pouch where the syringe locks into place was caused by a manufacturing failure at the component supplier.Breakage of the device/components cannot be confirmed as the luer lock remains in one piece.A dimensional inspection for the norian drillable inject 5cc-sterile was not performed as it is not applicable to the complaint condition.A functional test was unable to be performed since the syringe with the solution was not returned.However, leaking of the solution during usage is most likely due to the cracked condition of the luer lock.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the norian drillable inject 5cc-sterile would contribute to the complained device issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot part # 07.704.005s, synthes lot # ds7007178, supplier lot # ds7007178, release to warehouse date: 23 june 2021, supplier: (b)(4).No ncrs were generated during production.Device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.

• Brand Name: NORIAN DRILLABLE INJECT 5CC-STERILE
• Type of Device: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16138692
• MDR Text Key: 308721911
• Report Number: 8030965-2023-00416
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 10886982131614
• UDI-Public: (01)10886982131614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 07.704.005S
• Device Catalogue Number: 07.704.005S
• Device Lot Number: DS7007178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1