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

Model Number	16122-01-S
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not returned.If any additional information is provided, a supplemental report will be submitted.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2027467-2021-00052
• Device Sequence Number: 19624276
• Product Code: PDQ
• UDI-Device Identifier: 00190376240268
• UDI-Public: 00190376240268
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female