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

Model Number 16122-02-S

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 250817677
• Report Number: 2027467-2021-00027
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00190376240275
• UDI-Public: 00190376240275
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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 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
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization