MAUDE Adverse Event Report: OSTEOMED, LLC 2.4MM X 18MM VARIABLE ANGLE LOCKING SCREW

Catalog Number 359-2418

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently in progress.A supplemental report will be submitted upon completion of the investigation.

Event Description

On (b)(6) 2020, osteomed was notified that an implanted 2.4mm x 18mm variable angle locking screw (p/n 359-2418 ) and associated screws and plates were found to have migrated from the implanted location.The initial implant was performed on (b)(6) 2020 and the products were explanted on (b)(6) 2020.As per surgeon report "i saw the patient after 2 weeks and no complications were spotted.Due to the situation i suggested not to start the rehabilitation until the 4th post-operative week.After 4 weeks she came to my attention with pain and a severe alteration of the normal wrist anatomy.No trauma was reported by the patient and her family members.The x-ray showed early failure of the implant, displacement of the fracture and migration of two screws.During the procedure i've found complete loosening of all the screws with the only exception of the most proximal one, including all the locking screws.One screws was found 1.5 cm outside of the plate and still inserted on the plate hole, one was completely expelled (locking screw as well) and was found within the flexor tendons lying close to the median nerve" the following implants (plate and screws) were involved with this incident: 355-01114 hole vdr standard plate, left (qty.1).359-2416, 2.4mm x 16mm variable angle locking screw (qty.3) 359-2418, 2.4mm x 18mm variable angle locking screw (qty.3) 359-2712, 2.7mm x 12mm variable angle locking screw (qty.2) 358-2712, 2.7mm x 12mm cortex screw (qty.1) 358-2713, 2.7mm x 13mm cortex screw (qty.1).

Manufacturer Narrative

The 2.4mm x 18mm variable angle locking screw, part number 359-2418, associated screws and plate; and photos of the x-ray were supplied to osteomed.The product used in this case was inspected for any damage and no conclusive evidence was found.The surgeon, via email, and revision report dated (b)(6) 2020 suggested that patient has history of obesity, and severe reduction in mobility and admitted to using the operated limb post-operatively.Abnormal excessive stress on implants, excessive use of operated limb could lead to this early failure of implanted plates and screws by becoming unlocked/loosened prior to healing/union of bone or osteogenesis occurred.The root cause of this complaint is determined as "not used as indicated".The lot number was not provided.Therefore, a review of the dhr could not be performed.A 2-year review of capas, ncrs, and complaints was performed and found no similar issues.This plate is part of the extremilock wrist plating system and the risk document is fmea-0816, revision g.The risk of non-fusion of a fracture involving a plate and locked screw becoming "un-locked" postoperatively risk has a severity level of 3.Per sop-eng-006, a rating of 3 indicates a "serious" severity level (results in injury or impairment requiring professional medical intervention) and the final predicted risk is "medium".The instructions for use (ifu 030-1951, revision e) warning include: "3.The implants are not intended to endure excessive abnormal functional stresses.4.The osteomed extremilock wrist plating system is intended for temporary fixation only until osteogenesis occurs.6.Multiple/excessive bending may weaken the plate and could result in implant fracture and failure.16.Inform patient if he/she does not follow physician post-operative instructions and limitations of the internal rigid fixation implants, this may lead to premature device failure and subsequent patient injury.Failed devices may require re-operation and removal." complaints will continue to be monitored and trended.Note: complaint investigation results in this report is applicable to three 2.4mm x 18mm variable angle locking screw, p/n 359-2418 only.For plate and other screws investigation, results refer to the respective complaints (b)(4).

• Brand Name: 2.4MM X 18MM VARIABLE ANGLE LOCKING SCREW
• Type of Device: LOCKING SCREW
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho road; addison, tx
• MDR Report Key: 10197849
• MDR Text Key: 241054185
• Report Number: 2027754-2020-00006
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00845694092647
• UDI-Public: 0100845694092647
• Combination Product (y/n): N
• PMA/PMN Number: K152145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 359-2418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 85