MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT FOR 357.369; TRACTION,APPARATUS,NON-POWERED

Model Number 357.371

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Without a lot number, the device history records review could not be completed as no product was received.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

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the tfn locking tray are not working properly.The aiming arm metal clip has become loose.The threads of the buttress compression nut and blade guide sleeve are worn and not threading together properly, due to wear and tear.There was no surgical delay and no patient consequence.This is report 1 of 1 for (b)(4).

• Brand Name: BUTTRESS/COMPRESSION NUT FOR 357.369
• Type of Device: TRACTION,APPARATUS,NON-POWERED
• 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: 9536312
• MDR Text Key: 190764052
• Report Number: 2939274-2019-62813
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 10886982196057
• UDI-Public: (01)10886982196057
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 357.371
• Device Catalogue Number: 357.371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1