MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 95MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.304S
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient weight and date of birth are not available for reporting.Additional product code hwc.Device was implanted on (b)(6) 2017 and is currently explanted.Explant date is non-applicable.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.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 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) 11.0 mm ti helical blade and one (1) 4.5 mm 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.This is report 4 of 4 for (b)(4).
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.Device was implanted on (b)(6) 2017 and is currently implanted.Explant date is non-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.

• Brand Name: 11.0MM TI HELICAL BLADE 95MM-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7127997
• Report Number: 2939274-2017-50363
• Device Sequence Number: 1256106
• Product Code: HSB
• UDI-Device Identifier: 10886982226709
• UDI-Public: (01)10886982226709(17)EXPIRATIONUNKNOWN(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 456.304S
• Device Catalogue Number: 456.304S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR