MAUDE Adverse Event Report: ALPHATEC SPINE INVICTUS; TAP, BONE

Model Number 17109-055

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the tip of a 5.5mm tap broke into 3 pieces during surgery.All of the pieces were retrieved from the patient.

Manufacturer Narrative

H4.07/14/2021.H6.Investigation findings: 3252.Investigation conclusion: 61.H10.Additional information was received indicating the patient's bone was very hard.The surgeon inserted the 5.5mm tap over the k-wire per the surgical technique guide.Upon reaching the posterior cortex, the tip of the tap broke into 3 pieces, 2 of which had to be retrieved from the patient pedicle.It took about 20 minutes to retrieve.The patient reported feeling fine postoperatively.Device evaluation: taps may be used during pedicle preparation to facilitate screw insertion.The cannulation of the tap (through hole) is slid over the guidewire after the site has been dilated to the appropriate diameter.The bone is then tapped to the desired depth.Taps come in 4.5 mm, 5.5mm, 6.5 mm & 7.5 mm and are color coded by diameter.A review of the device history record did not identify any manufacturing or processing-related irregularities.They were found to be properly manufactured and released in accordance with design specifications.Instrument with qir and material certifications present and passing.Inspection of the id confirms in spec dimension of ø2.07mm which falls within required tolerance band of ø2.1mm ± 0.05mm.A hardness of rc 53.4 was tested which is also compliant with the rc 47 minimum requirement of 465 stainless steel.Visual inspection confirms tip of tap is broken.The break is angled, ununiform and jagged.Broken pieces not returned with instrument.No other observable signs of damage on remainder of instrument other than cosmetic scratches.Taps which fail due to purely torsional loads will experience distal twisting and/or shear fracture, typically proximal of the threads at the smaller od of the instrument.The fragmentation and angle of this tap fracture can only be achieved with large torsional loads accompanied by large bending loads.The surgeon likely had difficulty driving the tap through hard, cortical bone and as consequence, began to bend the instrument in effort to drive deeper into the bone.

• Brand Name: INVICTUS
• Type of Device: TAP, BONE
• Manufacturer (Section D): ALPHATEC SPINE; 1950 camino vide roble; carlsbad AR 92008
• Manufacturer Contact: wesley channell ; 1950 camino vide roble; carlsbad, AR 92008 ; 9014283693
• MDR Report Key: 15677586
• MDR Text Key: 306796067
• Report Number: 2027467-2022-00079
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 00190376192079
• UDI-Public: (01)00190376192079(10)NG105220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 09/27/2022

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: 17109-055
• Device Catalogue Number: 17109-055
• Device Lot Number: NG105220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male