MAUDE Adverse Event Report: MEDTRONIC MEXICO OSTEOCOOL BONE ACCESS KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number OCN005

Device Problem Break (1069)

Patient Problem Intraoperative Pain (2662)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-operative diagnosis for this procedure: compression fracture with tumor type of procedure: implant of pedicular screw for arthrodesis levels implanted: t5 and t6 it was reported that intra-op, when trying to remove the needle after the cement was delivered the hubs of the needle broke off making it extremely difficult to get the trocar out of the patient.There was a delay in overall procedure time.Patient had a lot of pain due to the force and wiggling of the needle it took to get it.No treatment or additional surgery performed as a result of this event.Pain was addressed by giving more pain medicines.No other post-op complications were reported.

Manufacturer Narrative

Product analysis results: visual and optical inspection confirmed the cannula was returned with the hub pulled from the shaft.On the cannula, the knurling was present as well as the flair on the backside of the shaft.There was cement noted inside the inner diameter of the hub.It appears the shaft was separated from the plastic hub from excessive force.If information is provided in the future, a supplemental report will be issued.

• Brand Name: OSTEOCOOL BONE ACCESS KIT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8765765
• MDR Text Key: 150248231
• Report Number: 9612164-2019-02732
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Catalogue Number: OCN005
• Device Lot Number: 216868716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other