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

Catalog Number 08.501.001.01S

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that a patient underwent an unknown open heart procedure on (b)(6) 2015.The sternum was closed with wires and five (5) sternal zipfix implants.The patient began experiencing trouble breathing approximately two (2) weeks post-operatively.Upon physical exam, the surgeon noted that sternum was unstable.A ct scan revealed that all of the implanted zipfix¿s were loose.The patient returned to the operating room on unknown date for device explantation.The surgeon commented that the locking mechanism on each of the implants did not function as intended; thus, the implants loosened.No additional information was available.(b)(4).

Manufacturer Narrative

Patient began experiencing symptoms approximately two (2) weeks postoperative, but the exact date of device loosening and symptom onset is unknown.Per facility, the complainant part has been discarded and is no longer available for return.(b)(4).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

• Brand Name: STERNAL ZIPFIX WITH NEEDLE STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4956311
• MDR Text Key: 20775154
• Report Number: 2520274-2015-15091
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.501.001.01S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 07/31/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 163