MAUDE Adverse Event Report: ALPHATEC SPINE INC ARCUS; ARCUS GUIDED ACCESS SYSTEM - DIAMOND TIP, STERILE

Model Number 16122-01-S

Device Problems Crack (1135); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not returned.If any additional information is provided, a supplemental report will be submitted.

Event Description

While malleting the arcus needle into the pedicle, the inner tocar cracked the outer sleeve of the jamshidi.The tocar became lodged within the bone which was very difficult to remove.The patient had very hard bone.

Manufacturer Narrative

Additional information: b5.No patient injury reported.H6: medical device problem code:1260 component code:752 type of investigation: 3331; 4114 investigation findings:3252 investigations conclusions: 23 device evaluation: the device history record was reviewed.No irregularities were identified during manufacturing or inspection.The device was not returned for evaluation.A photograph was provided to confirm the event.The root cause is the result of the cannula hub interface yields/strips at a lower force than the force required to remove the product from bone.This is likely result related to the manufacturing process.

• Brand Name: ARCUS
• Type of Device: ARCUS GUIDED ACCESS SYSTEM - DIAMOND TIP, STERILE
• Manufacturer (Section D): ALPHATEC SPINE INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: jayson alaba ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946771
• MDR Report Key: 12222179
• MDR Text Key: 265349899
• Report Number: 2027467-2021-00052
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00190376240268
• UDI-Public: 00190376240268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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 Model Number: 16122-01-S
• Device Catalogue Number: 16122-01-S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female