MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.160S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Event year is reported as 2020; however exact date of event is unknown.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.Device history lot: part number: 04.037.160s, synthes lot number: h847465, supplier lot number: n/a, release to warehouse date: mar 12, 2019, expiration date: jan 31, 2029, manufactured by synthes (b)(4).No ncrs were generated during production.Device history review: review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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 on (b)(6) 2020, a proximal femoral nailing system (tfna) nail broke.There were fragments generated and all broken and damaged pieces to the device were removed without difficulty or additional intervention.The broken tfna nail was removed and was revised with 4.5 lcp proximal femur plate.The patient was doing well.Concomitant device reported: unknown tfna helical blade (part#: unknown, lot#: unknown, quantity: 1); unknown locking screw (part#: unknown, lot#: unknown, quantity: unknown).This complaint involves one (1) device.This report is for (1) 11mm/130 deg ti cann tfna 400mm/right - sterile.This is report 1 of 1 (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10554337
• MDR Text Key: 207576892
• Report Number: 2939274-2020-04210
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096685
• UDI-Public: (01)10886982096685
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.160S
• Device Catalogue Number: 04.037.160S
• Device Lot Number: H847465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING