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

Catalog Number 357.371

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Event date: it is unknown when device became damaged.Implant and explant dates: device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and 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

(b)(6) reports that on an unknown date, a buttress/compression nut was worn and damaged.The product was no longer functional.It is unknown if there were patient or procedure involvement.This report is for a buttress/compression nut.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7827723
• MDR Text Key: 119031476
• Report Number: 2939274-2018-53528
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/29/2018
• 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