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

Catalog Number 329.30

Device Problems Material Fragmentation (1261); Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that when the plate-bending press handle is moved up and down it is shaving off metal and misaligned.This was found while pre-bending a plate prior to surgery, no surgery or patient involved.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Event date: unknown.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the service history records has been requested.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.

Manufacturer Narrative

A service history record review could not be performed because the reported lot number could not be validated or traced.A service and repair evaluation was performed for the subject device.The customer reported the handle was misaligned.The repair technician reported the item was worn out.¿worn out parts¿ are the reason for repair.The cause of the issue is unknown.The following parts were replaced: main body complete, pressure bolt complete, off-center cam, shaft extension handle, grip handle, upper anvil, lower anvil, lower anvil adjustment screw, and screw with spring.This item was repaired, passed synthes final inspection and returned to the customer on 27-apr-2015.The evaluation was confirmed.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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4723922
• MDR Text Key: 18652786
• Report Number: 2520274-2015-13384
• Device Sequence Number: 1
• Product Code: HXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 329.30
• Device Lot Number: XXXXXNA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• 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