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

Catalog Number 08.501.001.01S

Device Problem Fitting Problem (2183)

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

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.(b)(4).Device not implanted or explanted because of condition of use.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 during surgery on (b)(6) 2016 when they used the sternal zipfix it lost the fixation force.It was loose.The event did not affected the patient or the surgery time.No information about patient condition available.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4).Device returned to manufacturer.Device history record review was performed on part # 08.501.001.01s, lot # 9239126: manufacturing site: (b)(4), manufacturing date: 26 january 2015, expiry date: 01 january 2020: no non conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.Corrected data: manufacturer.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

The procedure was completed successfully with no patient harm.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device (sternal zipfix with needle sterile, part number 08.501.001.01s, lot number 9239126).The subject device was returned with the complaint condition stating that during surgery on 30.Nov 2016 when they used the sternal zipfix it lost the fixation force.It was loose.The event did not affect the patient or the surgery time.The procedure was completed successfully with no patient harm.The manufacturing documents were reviewed and no complaint related issues were found; this lot of (b)(4) implants was manufactured in january 2015.These devices are manufactured with injection moulding and successfully passed the required tensile test of the locking feature during the production procedure.The zipfix implant was sent to our cmf sustaining engineering group for a pd investigation: the implant was received cut in three parts.The binder was inserted in the locking head.The binder shows traces of wear that do not correspond to traces of tightening with the application instrument 03.501.080 as per surgical technique guide.The locking head of the returned part can be slide in both directions along the binder.No locking can be achieved; the part is not functional as per its design intent.The microscopic investigation found that the locking feature teeth are damaged because of misuse and mechanical overloading.The present damage coincides with the following scenario: the surgeon tried to release the implant by forcing the locking mechanism.This has damaged the locking mechanism to the point that the locking head can be moved in both directions, which as a result impairs the performance of the implant.According to the surgical technique for sternal zipfix, page 17, section implant removal), removal of the implant is only allowed by cutting the implant with the cable cutter, article number 391.905.No product related issue was identified and/or confirmed.The returned part was damaged per misuse.If intra-operative temporary release of the implant is required, the user should cut the implant and use an alternate device.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 PA 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: 6197071
• MDR Text Key: 63085788
• Report Number: 2520274-2016-15739
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Catalogue Number: 08.501.001.01S
• Device Lot Number: 9239126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1