MAUDE Adverse Event Report: NUVASIVE, INC. LATERAL ALIF ACCESS SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6973363
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an anterior lumbar interbody fusion procedure.During closure of the wound, a 5 mm pin broke off of the body of the retractor carriage and into the surgical wound.The piece was identified after closure of the wound, while taking final radiographic images.The wound was reopened and the pin was retrieved.No further patient impact was reported.
Additional Manufacturer Narrative
The complaint device was evaluated and the reported event was confirmed.The evaluation identified failure of the laserweld in place to join the pin component and the carriage body.Operative notes and/or radiograph images were not provided for review of usage/technique.A review of device manufacturing records was performed and no discrepancies were found.A definitive root cause was unable to be determined with the information provided but is likely the result of excessive use of force or technique.Labeling review: "pre-operative warnings: 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.Instruments should be protected during storage and from corrosive environments.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "intra-operative warnings: the physical characteristics required for many instruments do not permit them to be manufactured from implantable materials.If any broken fragments of instruments remain in the body of a patient, they could cause allergic reactions or infections.If an instrument breaks in surgery and fragments go into the patient, these pieces should be removed prior to closure and should not be implanted." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LATERAL ALIF ACCESS SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15136568
• Report Number: 2031966-2022-00137
• Device Sequence Number: 5234916
• Product Code: LXH
• UDI-Device Identifier: 00887517839923
• UDI-Public: 887517839923
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6973363
• Device Catalogue Number: N/A
• Device Lot Number: MS5382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Prefer Not To Disclose