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

Catalog Number 08.501.001.01S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.(b)(4).Device malfunctioned outside the operating room and was not implanted / explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Dhr review was completed.Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: 27 july 2016.Expiration date: 01 july 2021.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute 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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported during a demonstration of the device, the zipfix would not lock.It was reported the loop would not lock tightly.No patient involvement.This report is for one (1) sternal zipfix with needle.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

A product development investigation was performed.Locking teeth are slightly damaged on a few spots where the implant was manipulated with clamps.Locking mechanism is completely worn, showing that the implant has been mounted and unmounted many times.The returned device was inspected and compared to an intact sample.It was concluded that the locking mechanism of the returned part is faulty.Plastic deformations are clearly visible on the toothed surface of complained device.Moreover, the whole locking mechanism is located lower which prevents the ratchet to engage and provide locking.Such a level of deformation could not be replicated by using the comparison sample even after many times.Only excessive misuse can explain this level of deformation.Sustaining engineering did not identify any design related root cause which would explain the one device failure as seen in this complaint.Excessive demo use of the implant has probably led to this severe deformation of the locking mechanism which led to the failure to lock properly during demo.A design related root cause is excluded.This non-manufacturing investigation is closed by sustaining engineering as in-valid.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 development investigation was performed / investigation summary was updated with the following statements: ¿the video shows that the zipfix was unable to be tightened / locked while repeated testing.The testing was done in an office environment, there was no patient involvement.¿ 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: STERNAL ZIPFIX WITH NEEDLE STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6911920
• MDR Text Key: 88239840
• Report Number: 9612488-2017-10504
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2017

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 Expiration Date: 07/01/2021
• Device Catalogue Number: 08.501.001.01S
• Device Lot Number: L053116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 10/19/2017; 12/13/2017
• Supplement Dates FDA Received: 11/13/2017; 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1