MAUDE Adverse Event Report: OSTEOMED, LLC 1.6MM, 3 X 8 HOLES, "Y" PLATE; 1.6MM "Y" PLATE, LOCKING

Model Number 333-1603

Device Problems Device Difficult to Setup or Prepare (1487); Defective Device (2588); Insufficient Information (3190)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

The device will be evaluated once received and a supplemental report will be submitted upon completion of the investigation.

Event Description

On february 25, 2021 osteomed was notified that, during an implant of a 1.6mm, 3 x 8 holes, "y" plate (part 333-1603/lot 1145750) two (2) of the four (4) screws used did not lock in the plate.These 2 screws were identified as 1.6mm x 14mm full threaded screw, locking (part 330-1614/lot 1141838) and 1.6mm x 16mm full threaded screw, locking (part 330-1616 /lot 1130797).The implant and explant occur on (b)(6) 2021 during the same surgery.On march 02, 2021, osteomed was notified that, the surgery was prolonged for one hour and the patient had no consequences or impact.Per the reporter: "during the procedure, the specialist asks me for a hps 1.6 av block y plate with 11 holes (ref.333-1603, batch 1145750) from set 0056.The specialist asked me to cut it and i left it with 4 holes in the branch.After, placing the plate on the bone the specialist fixes it with a standard cruciform 1.6x10mm hps screw (ref.331-1610, batch.1148546) and a 1.6x8mm av hps locked screw (ref.330-1608, lot.1141744), on the branch.Then, he ask me for a drill to drill the proximal hole of the y-plate.The specialist measures and asks me for a 1.6x14mm av.Hps locked screw, (ref.330-1614, batch 1141838).During placement, when the doctor is blocking the screw, it continues through the hole in the plate and reaches the bone.The specialist removes the screw and the plate and asks me to verify the implant since the screw should lock in the plate.I perform the inspection of the plate and the locking.The specialist decides to reposition the screw on the plate, performs distal fixation and requests a 1.6x16mm av hps locked screw (ref.330-1616, lot.1130797) for the fixation in the hole already mentioned.During the locking of the screw it continues to the bone, again.The doctor removes the implanted plate and screws and performs reduction of the fracture with nails.The doctor asks me to report this event since it is not normal for this to happen with the implant." the following implants (plate and screws) were involved with this incident: 333-1603, lot 1145750 330-1614, lot 1141838 330-1616, lot.1130797.

Manufacturer Narrative

The 1.6mm, 3 x 8 holes, "y" plate (part 333-1603/lot 1145750), was returned to osteomed.However, the 2 screws that, did not lock in the plate were not returned.These two (2) screws were identified as 1.6mm x 14mm full threaded screw, locking (part 330-1614/lot 1141838) and 1.6mm x 16mm full threaded screw, locking (part 330-1616 /lot 1130797).The evaluation of the plate revealed two abnormalities, a manufacturing defect and a misshaped hole due to the plate cutting.These two irregularities would prevent the screw from locking into the plate, which allows the screw a mechanism to pass through the plate.A review of warehouse inventory shows that no plates from this lot were in stock.Addition visual inspection of current lots in inventory show no evidence of the abnormalities.Based on the investigation, the most likely root causes for this complaint are manufacturing defect and human error during plate cutting.The dhr was reviewed and no issues were found that, would contribute to the root cause.In addition, a 2-year review of capas, ncrs, and complaints was performed and no similar issues were found.This is the only complaint reported for this lot.There were no trends identified for this part number.This plate is part of the hand plating system and the risk document is fmea-0801, revision k.The failure mode for the locking feature has a severity of 1 for inability of achieve fixation with a locking screw.Per eng-006-f6, hazard list with severity rating, the hazard of a delayed procedure (major or equal to 30 min) has a severity rating of 2 (minor).Fmea-0801 adequately addresses this failure modes.The ifu 030-1612 revision w, hand plating system product information and instructions for use, include adequate user instructions and warnings for potential device failures.This issue will be monitored through routine trending.Note: complaint investigation results in this report is applicable to 1.6mm, 3 x 8 holes, "y" plate, part number 333-1603.For the associated screws investigation, results refer to the respective complaints (b)(4) (mdr 2027754-2021-00002) and (b)(4) (mdr 2027754-2021-00003).

• Brand Name: 1.6MM, 3 X 8 HOLES, "Y" PLATE
• Type of Device: 1.6MM "Y" PLATE, LOCKING
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd.; addison TX 75001
• MDR Report Key: 11600030
• MDR Text Key: 280515019
• Report Number: 2027754-2021-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00845694024839
• UDI-Public: (01)00845694024839(10)1145750(30)1(11)200128
• Combination Product (y/n): N
• PMA/PMN Number: K090522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 333-1603
• Device Catalogue Number: 333-1603
• Device Lot Number: 1145750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 66