MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ARCUS; TARGETING NEEDLE

Model Number	16122-02-S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Dr.(b)(6) malleted jamshidi into bone, once he put his k-wire in and went to take jamshidi out he was not able to get it out of the bone.He attempted to take a mallet to try and get jamshidi out and by doing this the entire jamishidi fell apart with the inner stylet still stuck in bone.We used multiple instruments to try and get it out and finally after 30 minutes of trying it came out.
Additional Manufacturer Narrative
B5.No patient injury reported.H6: medical device problem code:1260.Component code:752.Type of investigation:10; 3331.Investigation findings:3252.Investigations conclusions: 23.Device evaluation: the device history record was reviewed.The device returned to atec on (b)(6) 2021.It was given to engineering for further investigation.On (b)(6) 2021, engineering provided investigation results for this returned device.Visual inspection confirmed the sheaths of the arcus split and disassembled from the device.The cannula hub interface yields/strips at a lower force than the force required to remove the product from bone.The root cause is likely related to the manufacturing process.

• Brand Name: ARCUS
• Common Device Name: TARGETING NEEDLE
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: brian beireis ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946739
• MDR Report Key: 11821917
• Report Number: 2027467-2021-00027
• Device Sequence Number: 4308489
• Product Code: PDQ
• UDI-Device Identifier: 00190376240275
• UDI-Public: 00190376240275
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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?: No
• Device Expiration Date: 12/23/2025
• Device Model Number: 16122-02-S
• Device Catalogue Number: 16122-02-S
• Device Lot Number: 203588668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown