MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; ROD, FIXATION, INTRAMEDULLARY

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for an unknown nail head elements: tfna helical blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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) 2020, the trochanteric fixation nail advanced (tfna) nail helical blade would not insert into the 430 degree hole.The guide wire was hitting the nail before insertion into the helical blade.The surgeon used another nail to complete the procedure.The issue was during surgery and there was an unknown surgical delay.It is unknown if procedure was successfully completed.Concomitant devices reported: unknown insertion instruments: trauma (part#: unknown, lot#: unknown, quantity 1).This report is for one (1) unk - nail head elements: tfna helical blade.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5 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

There was a surgical delay of three (3) to five (5) minutes.The procedure was successfully completed.The patient outcome is unknown.

• Brand Name: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10600547
• MDR Text Key: 208992616
• Report Number: 2939274-2020-04380
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Patient Sequence Number: 1
• Treatment: 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; UNK - GUIDES/SLEEVES/AIMING; UNK - INSERTION INSTRUMENTS: TRAUMA; 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; UNK - GUIDES/SLEEVES/AIMING; UNK - INSERTION INSTRUMENTS: TRAUMA