MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMPRESSION IMPLANT DRILLING TEMPLATES; STAPLE, FIXATION, BONE

Model Number	EL-DTS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient mrn# reported as (b)(6).Lot number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a talonavicular revision surgery on (b)(6) 2018, to remove two (2) non-synthes screws.The surgeon used the elite compression implant drilling templates to revise the patient to staples.The surgeon drilled one part and placed a staple on the medial side successfully.The surgeon drilled and placed another staple on the dorsal side.The surgeon was not satisfied with the placement of the staple on the dorsal side and removed the staple.The elite compression implant drilling template was used to drill another part when it twisted and broke.The broken pieces were retrieved and did not enter the patient.The surgeon was able to successfully implant a wider staple on the dorsal side.A non-synthes screw and vivigen were added.Routine intraoperative x-rays were taken.The revision surgery was completed successfully with a two minute surgical delay.Patient outcome is unknown.Concomitant device: elite 30x20x20x20x20mm (4 legs) straight implant (part: el-3020s4, lot: unknown, quantity: 1).This report is for an elite drill kit - s shaped.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Patient¿s height reported as 6 feet 4 inches.Initially reported concomitant device is determined as not a concomitant device as it was not involved in malfunction.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ELITE COMPRESSION IMPLANT DRILLING TEMPLATES
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7740071
• Report Number: 2939274-2018-53160
• Device Sequence Number: 684016
• Product Code: JDR
• UDI-Device Identifier: 00810633021965
• UDI-Public: (01)00810633021965
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EL-DTS
• Device Catalogue Number: EL-DTS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 181