MAUDE Adverse Event Report: TRILLIANT SURGICAL 3.0/4.0MM CANN. SCREW DRIVER BIT: HEADLESS; TIGER HEADLESS CANNULATED SCREW SYSTEM SCREW DRIVER BIT

Model Number	212-40-003
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
While performing a lapidus procedure on a male patient in his (b)(6) with average bone quality, the surgeon experienced a 212-40-003 driver (lot # 19592-01-01) break while inserting a 202-30-034 tiger headless screw.The sales representative at the case, noted that the surgeon pre-drilled and prox-drilled prior to insertion.The surgeon utilized a k-wire and inserted the 202-30-034 tiger screw without any issues.Once the surgical site was sutured, it was realized that the 212-40-003 driver tip had broken off during surgery.Fluoro was utilized to detect the broken piece that remained in the patient (x-ray attached).The sales representative is following up with the surgeon to see how he plans to move forward.Information has not been received at this time.The broken 212-40-003 driver will be returned to for review while the 202-30-034 tiger headless screw and driver tip remains in the patient.
Additional Manufacturer Narrative
Notes to form 3500a and justification for information not provided (in initial or follow-up submission) as required per 21cfr803.52 is below.Trilliant surgical attempted to obtain the omitted information (items 1-10 below) as part of internal complaint handling activities.1.Patient date of birth (a2) and weight (a4) not reported.2.Catalog # and serial # (d4) not utilized by trilliant surgical.3.Expiration date (d4) not applicable (n/a) to non-sterile trilliant surgical products.4.Implanted date (d6) and explanted date (d7) n/a to this report.5.Reprocessor name and address (d9) n/a to this report.6.Concomitant medical products and therapy dates (d11) not reported.7.Pma/510(k) (g5) n/a to this report as the suspect medical device is a class i medical device (product code hxx).8.Section h7 n/a to this report as associated doctor has not reported of any remedial action.9.Section h9 n/a to this report.10.No files attached to this follow-up report.Initial submission contained an evaluation and conclusion memo which is still valid.Corrected information provided in follow-up submission, a1, b1 - adverse event and product problem are selected.B4, b6, b7, d1, d2 - common device name (product code is correct in initial submission), d3 - email address removed and fax number added.D4 - catalog #, serial #, d9, d10 - returned to manufacturer date corrected.E1 - initial reporter e-mail address added.G3 - health professional is selected in addition to distributor.H4, h5, h6 - patient code, device code, method codes (added to initial submission's selections), conclusion code, h9, h10 - corrected data.Additional information provided in follow-up submission g1 - name (and email address) updated as different personnel is submitting the follow-up submission than submitted the initial submission.G7 , h2 , h10 - additional manufacturer narrative.

• Brand Name: 3.0/4.0MM CANN. SCREW DRIVER BIT: HEADLESS
• Common Device Name: TIGER HEADLESS CANNULATED SCREW SYSTEM SCREW DRIVER BIT
• Manufacturer (Section D): TRILLIANT SURGICAL; 727 n. shepherd dr.; suite 100; houston TX 77007
• MDR Report Key: 7612352
• Report Number: 3007420745-2018-00006
• Device Sequence Number: 19287349
• Product Code: HXX
• UDI-Device Identifier: 00812926021911
• UDI-Public: (01)00812926021911(10)19592-01-01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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?: Yes
• Operator of Device: Physician
• Device Model Number: 212-40-003
• Device Catalogue Number: 212-40-003
• Device Lot Number: 19592-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR