MAUDE Adverse Event Report: SYNTHES USA STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK; CERCLAGE FIXATION

Catalog Number 08.501.001.05S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

Patient id/initial and age/date of birth are unknown.Udi: (01)20887587025985(17)expiration unknown(10)lot unknown.Device reportedly remains in the patient.Complainant part is not expected to be returned for manufacturer review/investigation.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.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.

Event Description

It was reported that a surgeon was using a sternal zipfix with needle sterile at the facility.One zip fix failed to tighten on one and broke after cutting on another.The surgeon was still able to use the one that failed to tightened by useing a clip on the sternal zipfix so it would not un-tighten and this remains in the patient.The surgeon finished the procedure with back-up devices that were readily available.There was no surgical time delay and no medical or surgical intervention.The surgery was successfully completed.The patient status outcome is unknown.Concomitant devices reported: application instrument (part unknown, lot unknown, quantity 1); cable cutter (part unknown, lot unknown, quantity 1).This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Initially reported there was no surgical delay.Correction: there was a five to ten minute surgical delay.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.

Event Description

It was reported that there was a surgical time delay of five to ten minutes.No unanticipated x-rays were taken.

Manufacturer Narrative

A product investigation was completed: the zipfix that would not tighten was left in patient as indicated in the description.The specific details regarding the application of force and method of use are unknown; therefore, no definitive root cause was able to be identified.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Per the technique guide, the sternal zipfix system is indicated for primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.Five (5) zipfix implants are recommended for a full midline sternotomy when no other plates are used for fixation.Relevant drawings for the device were reviewed (current and manufactured to revision.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.The specific details regarding the application of force and method of use are unknown; therefore, no definitive root cause was able to be identified.However, the failure is likely the result of the application of excessive forces prior to tensioning of the implant.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

Event Description

It was clarified that the sternal zipfix with needle that broke, broke after tightening and before the surgeon was able to cut it.It was removed and no other device as implanted.

• Brand Name: STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6210357
• MDR Text Key: 63486275
• Report Number: 2520274-2016-15783
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.501.001.05S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 UNKNOWN APPLICATION INSTRUMENT; 1 UNKNOWN CABLE CUTTER
• Patient Weight: 127