MAUDE Adverse Event Report: SYNTHES BRANDYWINE UNIVERSAL BENDING IRON; INSTR,BENDING OR CONTOURING

Catalog Number 329.031

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting, device is an instrument and is not implanted/explanted.Service and repair evaluation - the customer reported the handle broke.The repair technician reported handle cracked/broken as 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.

Event Description

It was reported by service and repair that a handle broke during a right mandible fracture surgery.Patient is doing well and there was no delay in surgery.This complaint involves 1 device.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A service history record review was attempted for the subject device; however, it could not be completed because the device is a lot/batch controlled item.A device history record (dhr) review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device is currently in the evaluation process at synthes customer quality the results of this evaluation are pending completion.Manufacturing location was corrected based on dhr results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product investigation summary: the returned device was sent for service and repair where the complaint condition was able to be confirmed as the handle was found to be broken.The device was deemed unrepairable and forwarded to customer quality for investigation.The distal most quarter of the handle was split longitudinally and broken off of the remaining handle.The device was checked for functionality and was found to operate as intended.The returned condition is consistent with extensive wear and repeated sterilization of the device over an extended lifetime.The handle material is phenolic le grade, which is susceptible to becoming brittle after being subjected to years of thermal cycling, which routinely occurs during sterilization cycles.The device is 10+ years old; therefore, the device age is likely a contributing factor.The universal bending iron is not noted in a system technique guide; however, it is covered on a product information sheet.The bending iron is designed to bend 2.4mm microvascular, universal fracture, locking reconstruction, and thorp plates in three dimensions: in-plane, out-of-plane and torsional.The relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision): top-level and handle.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.No definitive root cause was able to be determined; the returned condition is consistent with extensive wear and repeated sterilization of the device over an extended lifetime.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

• Brand Name: UNIVERSAL BENDING IRON
• Type of Device: INSTR,BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5536429
• MDR Text Key: 41764483
• Report Number: 1719045-2016-10277
• 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,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 329.031
• Device Lot Number: 5161556
• Other Device ID Number: (01)10887587039169(10)5161556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2006
• 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