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

Catalog Number 08.501.001.01S

Device Problem Break (1069)

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

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.(b)(4).Device broke intra-operatively and was not fully implanted or explanted.Complainant device 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 posterior zipfix tie popped/broke after being inserted during a sternal closure on (b)(6) 2017.There was a reported surgical delay of ten (10) minutes.Another tie was used.No fragments involved.No additional x-rays required.The procedure was completed successfully with the patient in stable condition.Concomitant device reported: zipfix tensioner/cutter (part # unknown, lot # unknown, quantity of 1).This report is for one (1) sternal zipfix with needle sterile this is report 1 of 1 for complaint (b)(4).

• Brand Name: STERNAL ZIPFIX WITH NEEDLE STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6988248
• MDR Text Key: 91446038
• Report Number: 3000270450-2017-10380
• 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: Other
• Type of Report: Initial
• Report Date: 10/09/2017

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: 08.501.001.01S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 10/30/2017
• 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