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

Catalog Number 03.501.080

Device Problems Loose or Intermittent Connection (1371); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: event date: unknown.Device is an instrument and is not implanted or explanted.Service & repair evaluation: the customer reported the item was sent in under recall #244.The repair technician reported the end cap was loose and that one of the side screws had been replaced with a hex screw that stripped and could not be removed.Unauthorized repair is the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit on october 23, 2015 for further investigation.Service history review: no service history review can be performed as this is a lot controlled item.The manufacture date of this item is march 19, 2012.The source of the manufacture date is the release to warehouse date.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.

Event Description

It was reported that an application instrument for sternal zipfix was returned as part of recall 244.During the repair process, it was discovered that the item had been altered with a hex screw in the center body above the trigger.During an internal evaluation of the returned product, which was completed on october 28, 2015, it was noted that the end cap was loose and that one of the side screws had been replaced with a hex screw that stripped and could not be removed.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product development investigation was performed for the subject device (application instrument for sternal zipfix, part number 03.501.080, lot number 7767497).The returned device was received intact with the exception of one screw, located directly below the cutting arm locking pin, which was missing and had been replaced with an unknown hex screw.The origin of the hex screw could not be identified.The end cap, which retains the spring, was found to be loose and could be disassembled by hand.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated as the spring is not retained as intended.The balance of the device shows substantial wear.The remaining functionality was tested and no further issues were determined.A review of the current design drawing/manufactured revision for the top level assembly was performed.The following component drawings were also reviewed; pusher assembly, end cap component, and pusher sleeve component.During the design review the following three items were determined; 1: this device lot number is included on recall #244 which was initiated because when using the 1st generation zip fix application instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.This has been addressed and is unrelated to the complaint condition.2: this lot number is also included in an action which has been implemented to address the side screws breaking.This condition likely resulted in a third party replacing the side screw with an unknown hex screw.3: a design change order (dco) revised the pusher assembly drawing in (b)(4) 2013 to add that the end cap is to be secured.This change was made after the manufacture date of the received device.Furthermore, this lot is part of an action which has been implemented to address instruments manufactured prior to the dco.Thus, the complaint condition was likely a result of design deficiencies that have been addressed.No additional issues or discrepancies were observed and the current designs were determined to be suitable for their intended use when employed and maintained as recommended.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 CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5216871
• MDR Text Key: 30983841
• Report Number: 3003875359-2015-10468
• 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
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

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: 7767497
• Other Device ID Number: (01)10887587010847(10)7767497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2475-2015
• Patient Sequence Number: 1