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

Catalog Number 03.501.080

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.A service and repair record review was attempted for the subject device.The review could not be performed because the device is a lot controlled item.The manufacture date of the subject device is oct 3, 2012.The source of the manufacture date is the release to warehouse date.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 the pulling/grabbing mechanism of the application instrument for sternal zipfix broke; a piece has broken off.It is unknown when the damage occurred; however, there was no report of patient or surgical involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the piece of the pulling/grabbing mechanism broke off.The repair technician reported the cutter broke off, and the item was part of a recall.Total rebuild needed is the reason for repair.The item is not repairable.The cause of the issue is unknown.The item will be forwarded to the complaint handling unit.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.

Manufacturer Narrative

A product investigation was completed: the returned application instrument for sternal zipfix (part 03.501.080, lot 8068078) is part of the sternal zipfix system intended for fast and stable fixation of the sternum, per the technique guide.The application instrument is designed to consistently tension and cut zipfix implants.In addition to a cutting edge being broken off, the returned application instrument was received with minor rouging of etched regions and superficial marks indicative of routine use.The returned application instrument for sternal zipfix was manufactured on october 03, 2012 and the relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.The returned part was included in a recall, which was not relevant to the subject complaint condition, therefore it was not considered as part of the subject failure mode investigation.No service history review could be performed as the returned instrument is a lot controlled item and its service history evaluation is unconfirmed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the lack of detailed information provided, it is not possible to determine a definitive root cause.Upon inspection of the returned instrument and considering the way it is used in surgery it is not likely that the broken cutting edge occurred during routine usage.The sternal zipfix system technique guide states that the user must avoid over-tensioning of implants, improper maintenance of instrument, improper positioning of cutting edge of the instrument in respect to implants, and improper positioning of the cutting lever when tensioning and cutting.In addition to not following the guidance provided in the technique guide it is possible that if the instrument was exposed to an unexpected significant impact due to mishandling it could have caused the cutting edge to break.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 CO CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CO CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5312033
• MDR Text Key: 33935452
• Report Number: 1719045-2015-10834
• 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,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8068078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2012
• 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-0276-2016
• Patient Sequence Number: 1