MAUDE Adverse Event Report: NUVASIVE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	D6950000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor were x-ray films provided to confirm the alleged event.Labeling review: ".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." intra-operative warnings ".Over-bending, notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.".
Event or Problem Description
It was reported during a spinal procedure the distal tan of a cage inserter snapped off in the patient.In an attempt to retrieve the part the surgeon cut a grove in the l5 level vertebrate.Product was successfully retrieved.
Additional Manufacturer Narrative
The device was evaluated and the reported event was confirmed.It was determined that the cause of the reported event, may be related to an error in surgical technique involving excessive and/or off axis forces being applied during the procedure causing stress to the engagement tangs.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8067136
• Report Number: 2031966-2018-00164
• Device Sequence Number: 11406895
• Product Code: LXH
• UDI-Device Identifier: 00887517705174
• UDI-Public: 00887517705174
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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 Model Number: D6950000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR