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

Catalog Number 329.30

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 the plate-bending press will not press and pins looked broken.Issue was found during an unknown surgery.The surgeon had a back-up device to complete the surgery.The procedure was completed successfully with no reports of delay or medical intervention.The patient's post-operative status was noted to be stable.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the item would not press and the pins looked broken.The repair technician reported the item was worn out in multiple areas, and some of the finishes were rough.Worn out parts is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.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.

Manufacturer Narrative

A product investigation was completed: this complaint is confirmed.The returned bending press was received in 9 separate pieces.The dowel pin which secures the handle to the bending housing has sheared in half.Unable to determine a definitive root cause.However, the complaint condition was most likely caused by application of excessive force or cumulative wear on this multiple use bending press.It is not likely that the design of the device contributed to this complaint.A visual inspection under 5x magnification, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.A review of the device history records was unable to be performed since the lot number was unknown.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The returned bending press is a reusable instrument used to contour/bend plates to better fit patient's anatomy in several systems including the large fragment lcp generic system.The relevant drawing was reviewed during this evaluation.No product design issues or discrepancies were observed.The complaint condition was most likely caused by application of excessive force or cumulative wear on this multiple use bending press.It is not likely that the design of the device contributed to this complaint.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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5816475
• MDR Text Key: 50297181
• Report Number: 2520274-2016-13606
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• 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: 07/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2016
• 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