MAUDE Adverse Event Report: OSTEOMED EXTREMILOCK ANKLE PLATING SYSTEM; 7 HOLE 1/3 TUBULAR PLATE

Catalog Number	336-0008
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The patient had surgery previously for an ankle fracture that is commonly corrected by the use of the 1/3 tubular plate and screws.Implants and surgery went well.The patient revisited with the physician and found that the plate was broken post-op.On (b)(6) 2019, the physician performed a hardware removal.
Additional Manufacturer Narrative
The returned 8-hole, 1/3 tubular, ankle plate broke post-operatively.The possibilities that might have caused a break post-operatively include: excessive bending of the plate pre-op, non-union of the fracture that placed abnormal, long-term stress upon the plate, a non-compliant patient, poor bone quality, design flaw, manufacturing flaw, and secondary trauma to the surgical site.Due to limited information, the exact root cause is unknown.Review of the dhr did not identify any non-conformances associated with lot release.A two-year review did not identify any capas or ncrs related to this implant family.This is the only complaint for this issue within the last two (2) years.This plate is a part of the extremilock ankle plating system (e-aps).The e-aps risk document includes an assessment of this failure mode.The risk of a non-union (presumed in this case) due to a broken platehas a predicted severity rating of 3.Per the risk management procedure, a rating of 3 indicates a "serious" severity level (results in injury or impairment requiring professional medical intervention).Depending on the possible cause, the final predicted risk level is either a "low" or a "medium".The e-aps instructions for use (ifu) outlines several contraindications, such as patients with certain metabolic diseases, or insufficient bone or poor bone quality, or disorders that would cause the patient to ignore the physician's pre- and /or post-operative instructions and/or the limitations of internal rigid fixation implants.The ifu has multiple user warnings such as patients must have sufficient bone quality to sustain effectiveness and benefits of rigid fixation, using undersized implants in areas of high functional stress may lead to implant fracture and failure, and bending the plate excessively multiple times may weaken the plate and could result in implant failure.The ifu also states the e-aps implants are not intended to endure excessive abnormal functional stresses, that they are intended for temporary fixation only until osteogenesis occurs, and that post-operative instructions should be given to the patient by the surgeon, including the potential for secondary injuries to a surgical site if the patient is non-compliant.This issue will be monitored through routine trending.

• Brand Name: EXTREMILOCK ANKLE PLATING SYSTEM
• Common Device Name: 7 HOLE 1/3 TUBULAR PLATE
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 8646368
• Report Number: 2027754-2019-00008
• Device Sequence Number: 19378765
• Product Code: HRS
• UDI-Device Identifier: 00845694049689
• UDI-Public: 00845694049689
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 336-0008
• Device Lot Number: 1126014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 07/01/2019
• 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