MAUDE Adverse Event Report: SYNTHES GMBH NORIAN DRILLABLE INJECT 10CC-STERILE; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number 07.704.010S

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 08/18/2022

Event Type  malfunction  

Event Description

It was reported that the (b)(6) 2022, when attempted to mix norian, the connection between the syringe that contains the mixing solution and the norian itself, would not lock properly, causing some of the solution to leak out.We attempted to complete the mixing but were unsuccessful.The procedure was successfully completed with 6min of surgical delay.No fragments were generated.No patient consequence was reported.This report is for one (1) norian drillable inject 10cc-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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Brand Name: NORIAN DRILLABLE INJECT 10CC-STERILE
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15396677
• MDR Text Key: 305626043
• Report Number: 8030965-2022-06637
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 10886982131621
• UDI-Public: (01)10886982131621
• 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: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 07.704.010S
• Device Catalogue Number: 07.704.010S
• Device Lot Number: DS7008989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1