MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ALIF TAP STRAIGHT (HANDLE); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 03.30.10.1580

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/06/2021

Event Type  malfunction  

Event Description

During an anterior interbody lumbar fusion procedure for a diagnosis of flat back syndrome, the tap that was used for the left upper screw at l5-s1 into the l5 vertebral body had sheared, and the tip of the bone tamp broke off.It could not be extracted since it was embedded into the dense bone.The surgeon chose to leave 3 screws in the l5-s1, the tip of the bone tamp in place to act as a screw, and 4 screws in l4-l5 construct.It is the opinion of the surgeon that the bone tamp is a solid construct (medtronic, pyramid), which is a 3-hole, 3 screw construct as a solid construct for l5-s1 and no need to "back up" with posterior pedicle screw fixation.The patient did well postoperatively and was discharged to home.Manufacturer response for orthopedic bone tamp, medacta bone tamp (per site reporter) the medacta rep was present in the or at the time of the event.

• Brand Name: ALIF TAP STRAIGHT (HANDLE)
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; 3973 delp street; memphis, TN 38118
• MDR Report Key: 11699750
• MDR Text Key: 246569639
• Report Number: 11699750
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2021

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 Operator: Health Professional
• Device Model Number: 03.30.10.1580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22995 DA
• Patient Weight: 102