MAUDE Adverse Event Report: SYNTHES (USA) PLATE-BENDING PRESS; INSTRUMENT, BENDING OR CONTOURING

Catalog Number 329.30

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Date of event: unknown.(b)(4) lot number unknown.Device is an instrument and is not implanted/explanted.A service and repair history record review will be requested once the lot/serial number of the device is identified.The subject device has been received and is currently in the evaluation process.Device manufacture date: unknown.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 a plate bending press was found missing the lower anvil during an unknown surgical procedure on an unknown date.Reportedly, the surgeon requested the plate bending device to bend an unspecified, non-synthes device.When the plate bending press was unwrapped the surgeon noted that the lower anvil was missing.It was suspected to be discarded or misplaced.The surgeon did not have a back-up device but was able to successfully complete the surgery as planned without the complained device.There was reportedly no delay to the surgery and no impact on the patient.The patient's postoperative status was reportedly fine.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.A service and repair evaluation was completed: the customer reported the lower anvil missing.The repair technician reported the lower anvil adjustment screw was worn, and the lower anvil was missing.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: lower anvil adjustment screw, lower anvil.The item was repaired per the inspection sheet, passed synthes final inspection 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: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5660440
• MDR Text Key: 46581959
• Report Number: 2520274-2016-12709
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• 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: 05/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2016
• 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