MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7 TI MULTILOC HUMERAL NAIL RT/CANN/240-S; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.016.240S
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2021, patient underwent a surgical procedure, while inserting an interlocking multliloc screw, the screw was too short.The surgeon continued to try to insert the multiloc screw possible stripping out the plastic insert of the multiloc humeral nail.The screw was pulled out of the bone and nail, and abandoned that screw hole procedure was completed successfully with a five(5) minutes surgical delay.No patient consequence reported.Concomitant device reported: unk - insertion instruments: trauma (part# unknown; lot# unknown; quantity: 1).This report is for one (1) 7 ti multiloc humeral nail rt/cann/240-s.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 7 TI MULTILOC HUMERAL NAIL RT/CANN/240-S
• 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: 12495719
• Report Number: 2939274-2021-05586
• Device Sequence Number: 5146099
• Product Code: HSB
• UDI-Device Identifier: 10886982089267
• UDI-Public: (01)10886982089267
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2021

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 Model Number: 04.016.240S
• Device Catalogue Number: 04.016.240S
• Device Lot Number: 1L96879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/20/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5 TI MULTILOC SCREW LENGTH 22-STERILE; UNK - INSERTION INSTRUMENTS: TRAUMA
• Patient Age: 77 YR
• Patient Weight: 49