MAUDE Adverse Event Report: NUVASIVE INC. ORTHOPEDIC MANUAL SURGICAL INSTRUMENT; GENERAL INSTRUMENTS

Model Number HD203T15

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for investigation nor were radiographs provided to confirm the alleged event.Multiple attempts have been made to try and retrieve further event information.Labeling: ".The instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury." ".Refer to cleaning and sterilization instructions below for all non-sterile parts.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." packaging ".Packages for each of the components should be intact upon receipt.Devices should be carefully examined for completeness, and for lack of damage, prior to use.Damaged packages or products should not be used, and should be returned to nuvasive." ".Do not use if package is opened or damaged." no product returned.

Event Description

Information received indicating product broke during a removal process.It is unknown why or what products were being removed or if patient was undergoing an initial or a revision procedure.

Event Description

Information received indicates product related to incident is not a nuvasive product.Mdr was inadvertently submitted.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Type of Device: GENERAL INSTRUMENTS
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8202843
• MDR Text Key: 131718663
• Report Number: 2031966-2018-00176
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00887517475688
• UDI-Public: 887517475688
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

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
• Device Operator: Health Professional
• Device Model Number: HD203T15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 03/26/2019
• Patient Sequence Number: 1