MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE 2.7MM ARSENAL SCREW DRILL BIT; ARSENAL PLATING SYSTEM DRILL, PRODUCT CODE: HTW

Model Number 330-27-001

Device Problem Dull, Blunt (2407)

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

Event Date 11/30/2021

Event Type  malfunction  

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 1-14 below) as part of internal complaint handling activities.Patient weight not reported.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Implant date and explant date was not entered as the drill is not implanted.There are no concomitant medical products and therapy dates.Initial reporter fax not provided.As the drill is a class i device, pma/510k number and device bla number is n/a to this report.Na was not entered within the fields as this caused technical errors to occur in previous mdr submissions.The device was not evaluated by the manufacturer.The device was not returned.No remedial actions were initiated.It is unknown if the usage of the device was initial or reuse as the information is not available.No files attached to this report.Investigation: evaluation of similar complaints: the complaints log was reviewed to identify any similar events involving arsenal drills cutting poorly between (b)(6) 2020 and (b)(6) 2021.Four (4) similar complaints were identified.Of these four (4) identified complaints, the root causes were as follows: no identified defect (x1) and tbd (x3).None of these related events can be confirmed to contain parts from the same lot number as the reported event as the lot number for the reported event is not confirmed.Device history record (dhr) review : the dhr for lot tsl010769 was reviewed to identify if any significant events occurred corresponding to the hardware involved in the event.Within lot tsl010769, no reworks (rwks) occurred.Nonconformance (ncr) 21-043 was identified.Ncr 21-043 was initiated due to feature 9 (point web) and feature 7 (verify presence of sharp edge with primary and secondary relief) failures for nineteen (19) parts.The lot was 100% inspected for the nonconforming features and all nonconforming product was scrapped.Thus, ncr (b)(4) does not correspond to the reported event. deviation (dev) 20-0027 was identified.Dev 20-0027 was initiated in response to capa (b)(4) for bent arsenal drill bit tips.The deviation included increased process controls for inspection as well as requiring three (3) devices to be tested via simulated use and subsequently scrapped.Thus, deviation 20-0027 does not correspond to the reported event.  review of surgical technique arsenal plating system instructions for use, 900-01-019 rev a, corresponds to the event.There are no abnormalities to document in regards to the user following the ifu.: the parts were not returned and could not undergo visual inspection.The parts were not returned and could not undergo dimensional inspection.Simulated use testing was performed utilizing a drill bit from inventory (part number: 330-27-001, lot number: tsl012179) in an attempt to recreate the reported event by drilling into pcf 50 sawbone (figure 1).Pcf 50 sawbone was utilized to represent a "worst-case" scenario of dense bone which would provide more resistance during drilling.Drilling was able to be performed a total of eight (8) times to simulate the repetitive use of the drill bits.No delay in initiation, drag, or smoking was observed during the simulated use testing.Thus, the event was unable to be recreated.Investigation conclusion : the parts from the complaint were not returned for evaluation.The lot number could not be confirmed to determine any definitive lot history which would have impacted the reported event.However, had the lot been released during the time period when deviation 20-0027 (such as the potential lot number evaluated), three (3) of the drill bits would have been functionally tested to confirm that user needs were met.Zero (0) lots failed for functionality during the implementation of deviation 20-0027.Simulated use testing with a drill bit from inventory could not recreate the reported event utilizing worst case materials.Revision a of the 2.7mm arsenal drill bits has undergone successful testing captured within the arsenal plating system 2.7mm pilot drill test report, doc-(b)(4).The 2.7mm arsenal drill bits met the acceptance criteria, which was to initiate into bone or bone analog with 2.5-4.0lbs axially loaded and to cut greater than or equal to 0.020" into 30 pcf sawbone within 15 revolutions at an axial load of 2.5lbs.Eight (8) samples were tested and found to have an average maximum depth of 0.09425", which exceeds the acceptance criteria requirement.Thus, the v&v testing completed for the drill bits are sufficient in addressing the design inputs.Despite the results of the simulated use testing and the v&v testing, the drill bit design shall be reviewed and updated based on the increase in drill bit complaints within the past calendar month (n=4).The updates are occurring within pr-21-004 (more specifically eco 21-0108) to enhance the drill bit design for the arsenal plating system.A new design for the drill bit is being implemented within pr-20-004 (arsenal ankle plating system) which is being evaluated for use within the arsenal plating system.Thus, the root cause of the sub-optimal ability of drilling (and the consequential contact of the drill into the surgeon's glove and fingernail) shall be attributed to the design material / specification.

Event Description

On 12/09/2021, djo f&a sales representative contacted djo f&a sales support specialist to report a complaint regarding a 330-27-001 (2.7mm arsenal screw drill bit) which malfunctioned during a 1st mpj fusion with a doctor at facility 1.Djo f&a sales representative stated that "the 330-27-001 had difficulty advancing down.The 330-27-001 would not drill down or cut to [the doctors] satisfaction.The doctor had to use increased force for the drill engage the bone and drill to desired depth.The doctor subsequently hit his other hand as the drill had slipped with the applied pressure.[the doctor] was able to complete the surgery successfully with the use of another drill." djo f&a sales representative did not retain the 330-27-001 and will not be sending it back to corporate for further review.

• Brand Name: 2.7MM ARSENAL SCREW DRILL BIT
• Type of Device: ARSENAL PLATING SYSTEM DRILL, PRODUCT CODE: HTW
• 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: 13177491
• MDR Text Key: 286502026
• Report Number: 3007420745-2022-00001
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00812926029689
• UDI-Public: (01)00812926029689(10)TSL010769
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 330-27-001
• Device Lot Number: TSL010769
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: No
• 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: 65 YR
• Patient Sex: Male