MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER; MISC ORTHO SURGICAL INSTR

Catalog Number 357.372

Device Problem Bent (1059)

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

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.Patient weight and date of birth are not available for reporting.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Without a lot number the device and service history records review could not be completed.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 a patient had initial surgery on (b)(6) 2017 for treatment of a sub-trochanteric femur fracture.Patient was implanted with one (1) trochanteric fixation nail (tfn), one (1) 11.0mm ti helical blade and one (1) 4.5mm distal locking screw.As the surgeon was using the slide hammer while inserting the helical blade implant with the helical blade coupling screw, the distal knob on the coupling screw broke off intraoperatively, and fell on the operating room floor.Due to the force that the surgeon used to disengage the helical blade implant from the tfn instruments, the aiming arm instrument and the helical blade inserter instrument became warped.Also, the buttress compression nut became stuck inside the blade guide sleeve.The surgeon successfully disengaged all the instruments from the implant, and proceeded with the surgery.No fragments were generated.Surgery was completed successfully with 30-40 minute time delay.Patient is reported in stable condition.(b)(4).

Manufacturer Narrative

Service and repair evaluation was completed.The customer reported the instrument became warped.The repair technician reported the alignment indicator was missing, and the handle was scarred.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: replacement alignment.The item was repaired per the inspection sheet, passed synthes final inspection on 2-jan-2018 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The previous service event for part number 357.372 with lot number(s) 5052982 has been reviewed.The customer called in a service request for this item on (b)(6) 2017 for inoperable - warped.The item was previously returned for service on (b)(6) 2017 due to etch unreadable.The previous service condition of etch unreadable is not relevant to the current complained issue of inoperable - warped.The manufacture date of this item is 29-jul-2005.The service history review is unconfirmed.Device history records review was completed for part # 357.372, lot # 5052982.Manufacturing location: (b)(4), release to warehouse date: jul 29, 2005.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: HELICAL BLADE INSERTER
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19026
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7126563
• MDR Text Key: 95798360
• Report Number: 2939274-2017-50354
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982196064
• UDI-Public: (01)10886982196064(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 357.372
• Device Lot Number: 5052982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR