MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER ROD,FIXATION,INTRAMEDULLARY

Model Number 456.355S

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Code Available (3191)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

Additional pro-code: hwc. Exp dae is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. A review of the device history record has been requested. (b)(4). 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) 2019, during the trochanteric fixation nail (tfn) left hip the locking mechanism would not engage. The locking mechanism in the tfn nail would not lock. The surgeon stated it would not lock and it felt stripped and the surgery was completed with the nail not being locked. There was no surgical delay. Patient status is unknown. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).

• Brand Name: 10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER
• 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: 8751028
• MDR Text Key: 149759107
• Report Number: 2939274-2019-58960
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K011857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2021
• Device Model Number: 456.355S
• Device Catalogue Number: 456.355S
• Device Lot Number: 7070973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2012
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 07/01/2019 Patient Sequence Number: 1