MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMPRESSION IMPLANT KIT 15X15X15MM 2 LEGS; BONE STAPLE

Model Number	EL-1515S2
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Device is not implanted/explanted.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 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 the inserter was stuck while inserting a bme elite implant during an unknown procedure on (b)(6) 2018.It will not release, so the staple came out and could not be implanted due to the issue with the inserter.There was a five (5) minute surgical delay and procedure was successfully completed.Patient outcome was good.This report is for one (1) elite compression implant kit 15x15x15mm 2 legs.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
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
The procedure performed was a foot surgery.Another staple was used to complete the procedure.

• Brand Name: ELITE COMPRESSION IMPLANT KIT 15X15X15MM 2 LEGS
• 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: 7814925
• Report Number: 2939274-2018-53476
• Device Sequence Number: 13821216
• Product Code: JDR
• UDI-Device Identifier: 00810633021675
• UDI-Public: (01)00810633021675
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 08/07/2018

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-1515S2
• Device Catalogue Number: EL-1515S2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 09/25/2018
• Patient Sequence Number: 1