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

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

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 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
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12495719
• MDR Text Key: 272175230
• Report Number: 2939274-2021-05586
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982089267
• UDI-Public: (01)10886982089267
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.016.240S
• Device Catalogue Number: 04.016.240S
• Device Lot Number: 1L96879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.5 TI MULTILOC SCREW LENGTH 22-STERILE; UNK - INSERTION INSTRUMENTS: TRAUMA
• Patient Age: 77 YR
• Patient Weight: 49