MAUDE Adverse Event Report: ALPHATEC SPINE, INC. AMP; BIT, DRILL

Model Number	117-160; 117-165
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Both the awl and drill bent while trying to put a lateral plate on causing a delay in surgery.
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow-up report with results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
Corrected data: h3: yes.H6: investigation findings: 213.Investigation conclusion: 67.H8: reuse.Additional information: h10: a review of the device history records did not identify any manufacturing or processing-related irregularities related to the screw shank geometry, tulip geometry, or other physical features.Qir reports indicate all inspected features were acceptable.Material certs were present from the supplier along with all other cofc's.Engineering could not duplicate the issue during in-house testing.The awl and drill both function with no issue, the center shaft slides within the sleeve without interruption.The root cause is unknown.The reported complaint could not be confirmed.

• Brand Name: AMP
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 14342470
• Report Number: 2027467-2022-00026
• Device Sequence Number: 4728585
• Product Code: HTW
• UDI-Device Identifier: 00190376195780
• UDI-Public: (01)00190376195780(10)8394701;(01)00190376228037(10)8645801
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): 04/11/2022

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: 117-160; 117-165
• Device Catalogue Number: 117-160; 117-165
• Device Lot Number: 8394701;8645801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown