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

Catalog Number 03.501.080

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

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

Event Date 06/10/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(6) reports an event as follows: it was reported that the handle of the zipfix application instrument stayed in the closed position during a sternal closure procedure on (b)(6) 2015.Also, it was discovered that one of the zipfix cable cutters was missing a tip blade when it came out of the set.Replacement devices were available for use.The procedure was completed successfully with no reported surgical delay.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing location: (b)(4) - manufacturing date: november 22, 2013.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this 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.

Manufacturer Narrative

A device evaluation investigation was performed: one application instrument for sternal zipfix (part number 03.501.080, lot number 8719722) was received with the complaint that the handle of the instrument stayed in the closed position.The complaint condition is unconfirmed for the zipfix application instrument as it functions as intended.There were no issues found with the returned device.The returned part was determined to be suitable for the intended use when employed and maintained.Further evaluation at the chu shows that this device is part of the sternal zipfix system and it is used to tension and cut the zipfix implants.Proper use and maintenance is addressed in the technique guide.The returned device was received intact and in very good condition.There are only a few wear marks on the surface of the device.When the cutting mechanism is locked, the trigger compresses and releases as intended.When the cutting mechanism is unlocked, the trigger is locked as intended so that the device would not cut with the implant under tension.Thus, the complaint condition for this device is unconfirmed and cannot be replicated.A review of the current design drawing was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.As an issue with the device was not identified and/or confirmed, review to the specific risk assessment is not applicable.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 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: 4868719
• MDR Text Key: 6048978
• Report Number: 3003875359-2015-10312
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

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: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 06/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2015
• 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