MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	456.305
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: hwc.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) 2020, the surgeon was putting a 100mm titanium helical blade into a trochanteric fixation (tfn) nail.The helical blade was halfway in and it would not advance or could not get it back out.The surgeon verified the side arm was at the same angle as the nail and verified that the anti-rotation mechanism was not interfering with the helical blade.The helical blade insertion handle was removed.The blade was easily removed with the slap hammer.The surgeon elected to remove the nail and replaced it with a new nail.The helical blade was also replaced with a new one.The procedure was completed successfully with no addition complications.The nurse had stated that the nail was reprocessed at the hospital because it was opened in a prior case by accident.No x-rays are available.There was a surgical delay of ten (10) minutes.Patient outcome was unknown.Concomitant devices reported: 11mm/130 deg ti cann troch fixation nail 400mm/right-ster (part number 456.420s, lot unknown, quantity 1), extraction instruments: cmf (part number unknown, lot unknown, quantity 1), insertion instruments: trauma (part number unknown, lot unknown, quantity 1), impaction inst: hammer/mallet: tr (part number unknown, lot unknown, quantity 1).This report involves one (1) 11.0mm ti helical blade 100mm.This is report 2 of 2 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 100MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10460226
• Report Number: 2939274-2020-03821
• Device Sequence Number: 3218426
• Product Code: HSB
• UDI-Device Identifier: 10886982226716
• UDI-Public: (01)10886982226716
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• 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): 08/03/2020

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: 456.305
• Device Catalogue Number: 456.305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM; UNK - EXTRACTION INSTRUMENTS: CMF; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - INSERTION INSTRUMENTS: TRAUMA