MAUDE Adverse Event Report: SYNTHES (USA) APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Catalog Number 03.501.080

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot number unknown.Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the customer complained about the instrument's corners, edges, and blind holes, stating that it is more complicated than a simple pair of scissors or tweezers with regard to cleaning to the cleaning process.This is a criterion of discernment for the customer's certifier.There was no patient or surgical procedure associated with the reported issue.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: depuy synthes assesses reusable medical devices in accordance with current national and international standards and guidelines, to determine whether a device can be effectively cleaned, disinfected and sterilized.A device review for cleaning, disinfection will include the intended use of the device, the design features of the device, device materials and the recommended cleaning process.A device review for sterilization will include the design features of the device, device materials, and the recommended sterilization parameters.In order to support reusable labeling claims, validation tests are performed for cleaning, disinfection and/or sterilization or the devices are validated by equivalence.To achieve a thorough and comprehensive review of cleanability, disinfection and/or sterilization of devices, every device is categorized in a group or family, that share common design features and characteristics.The worst-case representative of the group or family is established and challenged for cleaning, disinfection and/or sterilization effectiveness.If the device being reviewed is not considered worst-case in design in comparison to the devices in the group or family, then the device is considered validated by equivalence and is documented as such.Validation of cleaning, disinfection and sterilization will be performed after the standards, providing the acceptance criteria related to medical devices.The cleaned device is then tested along with controls to determine if the cleaning method was effective for the device by meeting the predetermined acceptance criteria according to the standards.Disinfection validation is performed due to a temperature profile of the devices.Steam sterilization validations typically are performed using the half-cycle method to meet the requirements.If the acceptance criteria are fulfilled, the device will pass.If the acceptance criteria are not fulfilled, the device will fail and the product developer has to redesign or change parts of it.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: APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
• Type of Device: CERCLAGE FIXATION
• 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: 5299754
• MDR Text Key: 33588133
• Report Number: 2520274-2015-17925
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.501.080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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