MAUDE Adverse Event Report: OSTEOMED FOOT PLATING SYSTEM; FPS¿ 3.5/4.0MM 10 HOLE T PLATE

Model Number	324-2222
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(4) 2018, osteomed was notified that 6 months post surgery, the fps¿ 3.5/4.0mm 10 hole t plate (p/n 324-2222) broke.
Event or Problem Description
On (b)(6) 2018, osteomed was notified that 6 months post surgery, the fps¿ 3.5/4.0mm 10 hole t plate (p/n 324-2222) broke.
Additional Manufacturer Narrative
The plate was implanted on (b)(6) 2017.Osteomed was notified on (b)(6) 2018, that the plate broke.This is over 6 months post-implantation.Based upon additional information received from the distributor, the bone had not healed.It was implanted for medial column instability.Post-surgical instructions included non-weight bearing activity for eight (8) weeks and physical therapy.The physician reported that the patient was compliant with these instructions.Since the surgery, the patient has not experienced any trauma to the food that would have caused this incident.The physician is planning to explant the plate, but is still evaluating the patient.Based upon the information received, the root cause is associated with improper surgical technique, as the incorrect plate for an intended medial column fusion procedure.The fps 3.5/4.0mm 10 hole t plate was not designed for medial column fusion surgery.This plate used was designed for fracture repair, but was used in a procedure that did not involve fractures.This plate is listed as a "medium fragment plate" in the foot plating system (fps) surgical technique guide (stg).The surgeon did not use one of the medial column fixation plates supplied in the foot plating system; either the large medial column plate, or the small medial column plate, for this surgery.Per the stg, each of these plates is specifically designed for fusion of the medial column bones.The bones did not fuse even after 6 months.Since the patient only restricted weight bearing for the first 8 weeks, the following 4 months forced the plate to experience excessive abnormal functional stresses of "normal" walking activities that it was not designed to handle.This combination lead to the break.The review of the device history record for this lot did not identify any non-conformances associated with lot release.A two-year review of capas and ncrs did not identify any internal investigations or non-conformances associated with this device.The review of the complaint history shows that this is the first complaint ever received for this device.This plate is a part of the foot plating system.Per the fps failure mode and effects analysis is fmea, the potential failure mode of a plate breaking is covered and has two risks, non-union and tissue irritation.The severity rating for "non-union" is a 3 (serious), and a 1 (negligible) for "tissue irritation".All final risk levels are "low".The instructions for use guide warns that this implant is not intended to endure excessive abnormal functional stresses, is intended for temporary fixation only until osteogenesis occurs, and warns that post-operative instructions should be given to, and carefully followed by, the patient, including the knowledge of the potential for secondary injuries to a surgical site if the patient is non-compliant.It also warns that bending the plate multiple times may weaken the plate and could result in implant failure.This issue will be monitored through routine trending.

• Brand Name: FOOT PLATING SYSTEM
• Common Device Name: FPS¿ 3.5/4.0MM 10 HOLE T PLATE
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 7205608
• Report Number: 2027754-2018-00001
• Device Sequence Number: 13702541
• Product Code: HRS
• UDI-Device Identifier: 00845694023122
• UDI-Public: (01)00845694023122(10)1033338(30)1(11)100420
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K091614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: Physician
• Device Model Number: 324-2222
• Device Catalogue Number: 324-2222
• Device Lot Number: 1033338
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/20/2018
• 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
• Patient Weight: 65