MAUDE Adverse Event Report: SYNTHES HAGENDORF APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Catalog Number 03.501.080

Device Problem Mechanical Jam (2983)

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

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(6) reports an event as follows: during surgery, one zipfix application instrument malfunctioned during a sternal closure procedure.The handle of the instrument stayed in the closed position.There was no reported surgical delay, and no reported patient harm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not provided.Implant and explant dates: device is an instrument and is not implanted/explanted.Initial reporter: contact phone number / extension: (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; 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.

Manufacturer Narrative

A product development evaluation was performed for the subject device (part number 03.501.080, application instrument for sternal zipfix, lot number 8719722).The subject device is a second generation was received with no components, screws or nuts loose or missing.Functional testing revealed, as per the complaint description, that the trigger of the instrument did not always function freely.However, after the instrument was lubricated as per the manufacturer¿s instructions, the function of the instrument was fully restored and three implants could be tensioned and cut as per the design intent.The root cause of the functional issue is related to the not preformed lubrication of the device by the user.No design related issues could be identified by product development.In conclusion, the non-manufacturing product development investigation of the second generation zipfix instrument is closed as determined as being invalid.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 HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4841663
• MDR Text Key: 5914985
• Report Number: 3009450863-2015-10017
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8719722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2015
• Initial Date FDA Received: 06/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/26/2015; 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2013
• 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