MAUDE Adverse Event Report: EPIC EXTREMITY EPIC PLATE SYSTEM; BONE FIXATION PLATE, SCREW

Catalog Number 2001-3522

Device Problem Defective Device (2588)

Patient Problem Infiltration into Tissue (1931)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the complaint devices were not returned for analysis.A pull through test was conducted using similar parts.The screws were tightened against the plate on-axis (+/- 12.5-degrees), at 20-degrees off-axis, and 30-degrees off-axis.Further testing was conducted using the newly designed locking screws.The most likely root cause was attributed to a design issue that allows the screws to be pulled through the plate holes when tightened at > 30-degrees off-axis.As corrective action, the non-locking screw was redesigned to a locking screw and the previous design was discontinued.Per engineering change order ((b)(4)), no further action was required.This device is used for treatment, not diagnosis there is no additional information on the event, patient, or devices.Concomitant devices: 0mm plate -2000-2000, sn: (b)(4).2001-3518 18mm 3.5 nonlocking screw, sn: (b)(4).2.7 drill bit 2100-2700, sn: (b)(4).

Event Description

As part of due diligence conducted during a company acquisition audit this complaint was determined to be reportable for fda mdr.This medwatch is being reported by this company on behalf of the listed manufacturer found.It was reported that a patient experienced a surgery for a lateral column lengthening of the calcaneus on (b)(6) 2016.During the procedure the plate was placed over a cadaver graft in the calcaneus to fixate the wedge in the plate.The plate was chosen by the surgeon and placed in the patient.One 3.5 non-locking screw was placed in the anterior process of the calcaneus through the plate after being drilled with a 2.7mm drill.The next screw was driven on the opposite side to the osteotomy with the 2.7mm drill and then a 3.5 mm non-locking screw was screwed into the plate.The screw was ratcheted down with a hand driver and continued through the plate completely.The surgeon removed the plate and screw to reposition the plate.The surgeon put another screw in the patient which went through the plate again.The screw went through the inferior plate hole this time, this occurred in two different screw holes.Alternative hardware from another manufacturer was used.The patient endured 45 minutes of additional anesthesia time due to the delay in surgery.There is no additional information on the event, patient, or devices.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2019-00001 and 1038671-2019-00002.

Event Description

As part of due diligence conducted during a company acquisition audit this complaint was determined to be reportable for fda mdr.This medwatch is being reported by this company on behalf of the listed manufacturer found in d3.It was reported that a patient experienced a surgery for a lateral column lengthening of the calcaneus on (b)(6) 2016.During the procedure the plate was placed over a cadaver graft in the calcaneus to fixate the wedge in the plate.The plate was chosen by the surgeon and placed in the patient.One 3.5 non-locking screw was placed in the anterior process of the calcaneus through the plate after being drilled with a 2.7mm drill.The next screw was driven on the opposite side to the osteotomy with the 2.7mm drill and then a 3.5 mm non-locking screw was screwed into the plate.The screw was ratcheted down with a hand driver and continued through the plate completely.The surgeon removed the plate and screw to reposition the plate.The surgeon put another screw in the patient which went through the plate again.The screw went through the inferior plate hole this time, this occurred in two different screw holes.Alternative hardware from another manufacturer was used.The patient endured 45 minutes of additional anesthesia time due to the delay in surgery.There is no additional information on the event, patient, or devices.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2019-00001 and 1038671-2019-00002.

Manufacturer Narrative

Section h10: (h3): the complaint devices were not returned for analysis.A pull through test was conducted using similar parts.The screws were tightened against the plate on-axis (+/- 12.5-degrees), at 20-degrees off-axis, and 30-degrees off-axis.When using a 5mm diameter head (original head design), staying within +/-12.5 degree off axis allows for proper installation.When off axis is greater than 12.5 degrees risk is introduced to pull screw through plate, likelihood of risk increases as off axis angle increases.Further testing was conducted using the newly designed locking screws.When using 5.5mm diameter head (new head design), proper installation was achieved at all off axis angles up to +/- 30 degrees off axis, which was the screw insertion limit.The most likely root cause was attributed to a design issue that allows the screws to be pulled through the plate holes when tightened at > 30-degrees off-axis.As corrective action, the non-locking screw was redesigned to a locking screw and the previous design was discontinued.Per engineering change order (eo-00012), no further action was required.This device is used for treatment, not diagnosis there is no additional information on the event, patient, or devices.(d11); concomitant devices 0mm plate -2000-2000 sn: (b)(4).2001-3518 18mm 3.5 nonlocking screw sn; (b)(4).2.7 drill bit 2100-2700 sn: (b)(4).

• Brand Name: EPIC PLATE SYSTEM
• Type of Device: BONE FIXATION PLATE, SCREW
• Manufacturer (Section D): EPIC EXTREMITY; 120 marguerite drive; ste 301; cranberry townshi PA 16066
• MDR Report Key: 8743976
• MDR Text Key: 149555244
• Report Number: 1038671-2019-05044
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K153340
• 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: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2001-3522
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2.7 DRILL BIT 2100-2700, SN: (B)(4); 2001-3518 18MM 3.5 NONLOCKING SCREW, SN: (B)(4); 2.7 DRILL BIT 2100-2700, SN: (B)(4); 2001-3518 18MM 3.5 NONLOCKING SCREW, SN: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR