• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE PETITE MPJ VLC GRIDLOCK PLATE, LEFT GRIDLOCK PLATING SYSTEM PLATE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE PETITE MPJ VLC GRIDLOCK PLATE, LEFT GRIDLOCK PLATING SYSTEM PLATE Back to Search Results
Model Number 300-52-005
Device Problem Fracture (1260)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Event Description
On 04/25/2022, djo f&a sr. Regional account coordinator received a complaint from djo f&a independent sales representative of a removal case including the following parts: 300-52-005 (petite mpj vlc gridlock plate, left), 301-30-014 (3. 0mm x 14mm gl screw), 302-30-010 (3. 0mm x 10mm gl locking screw), 302-30-012 (3. 0mm x 12mm gl locking screw), (2) 302-30-014 (3. 0mm x 14mm gl locking screw), 302-30-016 (3. 0mm x 16mm gl locking screw), at facility 1 by doctor 1 on a 67 year old female patient. Djo f&a independent sales representative stated that the original implant took place at facility 2 on (b)(6) 2016 with doctor 2. The removal case was completed due to "non-union and screws and plates sticking through the skin".
 
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. Patient weight not reported. Catalog # and serial # not utilized by trilliant surgical. Date of event is unknown. The event is considered to be when the patient experienced the plate breakage. Expiration date not applicable (n/a) to non-sterile trilliant surgical products. Initial reporter fax not provided. Reprocessor name and address n/a to this report. Device bla number 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 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 gridlock plate device failure and / or non-union between april 2021 and april 2022. No similar complaints were identified. Device history record (dhr) review dhrs were reviewed to identify if any significant events occurred corresponding to the hardware involved in the event: within lot tsl003243 (300-52-005), no reworks (rwks) or deviations (dev) occurred. Nmr 16-014 was initiated for parts failing for feature 3 (hole distance), 4 (hole distance), 5 (hole distance), 6 (hole distance), 7 (hole distance), 8 (hole distance), 12 (locking screw hole),15 (thickness). Parts failing for hole distance only were dispositioned as "uai", as the hole distance was determined to not impact the form, fit, function, or risk associated with the parts. The other failing parts were scrapped. Thus, it is not expected that nmr 16-014 pertains to the reported event. Within lot tsl000991 (301-30-014), no significant events [reworks (rwks), nonconformances (ncrs), or deviations (dev)] occurred. Within lot 24236 (302-30-010), no significant events [reworks (rwks), nonconformances (ncrs), or deviations (dev)] occurred. Within lot tsl002332 (302-30-012), no significant events [reworks (rwks), nonconformances (ncrs), or deviations (dev)] occurred. Within lot tsl002580 (302-30-014), no significant events [reworks (rwks), nonconformances (ncrs), or deviations (dev)] occurred. Within lot tsl002336 (302-30-016), no significant events [reworks (rwks), nonconformances (ncrs), or deviations (dev)] occurred. Review of surgical technique: gridlock plating system instructions for use, ifu 900-01-006 revision n corresponds to the event. Limited information was provided for the surgical technique / conformance to the ifu, so it is unknown if the physician / user was described to have followed the ifu. Visual inspection: the complaint related parts were returned. The plate had bone particulates from being implanted for ~6 years. There were burrs observed in the locking holes of the plate, which is expected to be resulting from the stress placed on the plate and screw interaction during and following the breakage. One of the breakage sites appears to be "smooth", which may correspond to frequent interaction with other hardware and may indicate that the breakage occurred a while ago. Dimensional inspection: due to the nature of the breakage, dimensional inspection would not be able to occur for features of interest. Thus, dimensional inspection did not occur. Simulated use testing: due to the limitations of trying to recreate the failure mode of non-union and device failure (i. E. , not being able to simulate physiological conditions for the implantation time of ~6 years as well as any potential external stresses applied to the construct), simulated use testing did not occur. Investigation conclusion: no similar complaints were identified. There are no abnormalities to report in regards to dhr review. Limited information was provided regarding the implantation surgical technique. Thus, it is unknown if the user followed the ifu during the implantation procedure. Visual inspection confirmed the breakage. Dimensional inspection did not occur. Simulated use testing did not occur. Based on how the breakage occurred with a portion of the plate "folding over" another portion of the plate, it is expected that excessive abnormal stress was applied to the construct resulting in the breakage and non-union. However, patient noncompliance was not reported. As a result, the root cause of the device failure and non-union remains unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePETITE MPJ VLC GRIDLOCK PLATE, LEFT
Type of DeviceGRIDLOCK PLATING SYSTEM PLATE
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
8004952919
MDR Report Key14472867
MDR Text Key294786090
Report Number3007420745-2022-00006
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00812926025360
UDI-Public(01)00812926025360(10)TSL003243
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130964
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 05/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number300-52-005
Device Lot NumberTSL003243
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2022
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/23/2022 Patient Sequence Number: 1
Treatment
301-30-014, 3.0MM X 14MM GL SCREW; 302-30-010, 3.0MM X 10MM GL LOCKING SCREW; 302-30-012, 3.0MM X 12MM GL LOCKING SCREW; 302-30-014, 3.0MM X 14MM GL LOCKING SCREW (QTY 2); 302-30-016, 3.0MM X 16MM GL LOCKING SCREW
-
-