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

Model Number	EL-DTS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2018, during the midfoot fusion procedure, one of the elite compression implant drilling templates in the set broke in the middle of the procedure.The surgeon was able to use an alternative, the second elite compression implant drilling templates in the set.There was no surgical delay.The procedure was completed successfully.The event did not affect the patient.This report is for one (1) elite compression implant drilling templates.This is report 1 of 1 for complaint (b)(4).

• Brand Name: ELITE COMPRESSION IMPLANT DRILLING TEMPLATES
• Common Device Name: BONE, STAPLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8205703
• Report Number: 2939274-2018-55637
• Device Sequence Number: 14113634
• Product Code: JDS
• UDI-Device Identifier: 00810633021965
• UDI-Public: (01)00810633021965
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/31/2018
• Patient Sequence Number: 1