MAUDE Adverse Event Report: SYNTHES USA PLATE-BENDING PRESS; INSTR,BENDING OR CONTOURING

Catalog Number 329.30

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.Date of event is unknown.(b)(4).Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Reporter contact number: (b)(6).No service history review can be performed because the lot/serial number is unknown and cannot be traced.The manufacture date is unknown.The service history review is unconfirmed.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.Device 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) reported that a plate bending press was found broken or non-functioning by the hospital facility.There is no reported patient or procedure involvement.This report is for one (1) plate-bending press.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Service and repair evaluation was completed.The customer reported the item was broken.The repair technician reported the pressure roller was sticking.Binding is the reason for repair.The cause of the issue is unknown.The following parts were replaced: main body, pressure bolt, lower anvil, lower anvil adjustment screw, pin, screw with spring (2).The item was repaired per the inspection sheet, passed synthes final inspection on (b)(6) 2016 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.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.

• Brand Name: PLATE-BENDING PRESS
• Type of Device: INSTR,BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6116409
• MDR Text Key: 60438124
• Report Number: 2520274-2016-15454
• Device Sequence Number: 1
• Product Code: HXP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 10/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 329.30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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