MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.328S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: hwc.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2021 during an intramedullary femoral nail procedure, the ti helical blade and the ti trochanteric fixation nail were stuck together.Upon insertion of the ti helical blade through the ti trochanteric fixation nail, it collided with the internal locking mechanism.Both implants were removed and replaced successfully using back up devices.The procedure was successfully completed without surgical delay.There was no patient consequence.The patient outcome is unknown.This report is for one (1) 11mm/130 deg ti cann troch fixation nail 235mm-sterile.This is report 2 of 2 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-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: 11673484
• Report Number: 2939274-2021-01868
• Device Sequence Number: 19707110
• Product Code: HSB
• UDI-Device Identifier: 10886982227027
• UDI-Public: 10886982227027
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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 Expiration Date: 02/28/2024
• Device Model Number: 456.328S
• Device Catalogue Number: 456.328S
• Device Lot Number: 7944429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11.0MM TI HELICAL BLADE 100MM-STERILE
• Patient Age: 88 YR