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

Model Number EL-1515S2

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant device is not expected to be returned for manufacturer review/investigation.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 Description

It was reported that the surgeon was attempting to implant one of the bme elite staples in proximal tibia when the staple would not release from the handle (the release trigger would not move).The surgeon was pulling with two hands to release the trigger and it would not release.The sales consultant opened a second implant and it worked perfectly.The surgery continued without incident and there was not patient consequence.This is report 1 of 1 for complaint (b)(4).

• Brand Name: ELITE COMPRESSION IMPLANT KIT 15X15X15MM 2 LEGS
• Type of Device: STAPLE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES BME : SAN ANTONIO; 14785 omicron drive; #205; san antonio TX 78245
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7514889
• MDR Text Key: 108369409
• Report Number: 2939274-2018-52182
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633021675
• UDI-Public: (01)00810633021675
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL-1515S2
• Device Catalogue Number: EL-1515S2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1