MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE 4.5MM X 40MM LTTCS; SCREW, FIXATION, BONE

Model Number	200-45-140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, an independent sales representative, emailed the complaints inbox to report a complaint of a 200-45-140 (4.5mm x 40mm lttcs) which broke during a case at hospital 1 - with dr.1.The independent sales representative stated in his email "just had a tiger 4.5 long thread break while inserting under heavy pressure on super hard bone" and that "we got the head out (picture) leaving threaded distal end in since it's across the joint." brad provided photos of the intra-operative x-ray and removed broken 200-45-140 screw head.
Additional Manufacturer Narrative
Notes to form 3500a and justification for information not provided 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.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Lot # and udi # could not be confirmed.All lot possibilities are listed below.Reprocessor name and address n/a to this report.Device bla number (g4) is n/a to this report.Na was not entered within the field for bla number as this caused technical errors to occur in previous mdr submissions.Section n/a to this report.Section h9 n/a to this report.No files attached to this report.Investigation: evaluation of similar complaints: the complaints log was reviewed to identify any similar events involving a subtalar removal between november 2021 and november.2022.No similar complaints were identified.Device history record (dhr) review: there were no identified issues related to the complaint event.Review of surgical technique: limited information was provided for the surgical technique / conformance to the ifu.* visual inspection: the parts were not returned.Thus, visual inspection did not occur.Dimensional inspection: the parts were not returned.Thus, dimensional inspection did not occur.Simulated use testing: as the part was not returned and limited information is available, simulated use testing did not occur.Investigation conclusion - there were no similar ccrs within the time period reviewed.There were no abnormalities regarding dhr review.Limited information was provided regarding the case.Thus, it is unknown if the user followed the proper surgical technique.It was reported that the screw broke "while inserting under heavy pressure on super hard bone" per reporter bm after being present at the case with dr.Nowak.As the part was not returned, visual inspection and dimensional inspection did not occur.Simulated use testing did not occur.Based on the information provided by reporter bm, the root cause can be attributed to excessive torque - from a combination of the "heavy pressure" that the doctor may have applied to the screw as well as from the hard bone of the patient.

• Brand Name: 4.5MM X 40MM LTTCS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston TX 77007 1320
• Manufacturer (Section G): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston TX 77007 1320
• Manufacturer Contact: kayla gary ; 727 north shepherd drive; suite 100; houston,, TX 77007-1320 ; 8004952919
• MDR Report Key: 15891066
• Report Number: 3007420745-2022-00008
• Device Sequence Number: 14757035
• Product Code: HWC
• UDI-Device Identifier: 00812926028989
• UDI-Public: 00812926028989
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2022

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: 200-45-140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male