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

Catalog Number 08.501.001.01S

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Udi: (b)(4).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Reporter phone number: (b)(6).A device history record (dhr) review was performed for part # 08.501.001.01s, lot # l035723: manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 19 july 2016, expiry date: 01 july 2021: no anomalies were detected during device history record review.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.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 europe reports an event in (b)(6) as follows: it was reported that during a surgery on (b)(6) 2017, the sternal zipfix dropped out while being used on patient.They changed the device and used another one to complete the surgery.There is no report of patient's injury.No surgical delay is reported.Procedure was completed successfully.Concomitant device reported: unknown instrument (part # unknown, lot # unknown, quantity 1).This report is for one (1) sternal zipfix with needle sterile.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device.Only a part including the locking head of approximately 260 mm length of the complained zipfix implant was received for investigation.The remaining and around 31 mm measuring part was not received and is missing.The available portion of the implant shows various damage and deformation.The binder shows traces of wear and marks that do not correspond to common traces of tightening with the application instrument 03.501.080 as per surgical technique.The locking head of the returned part shows marks of a forceps and 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, removal of an already closed implant is only allowed by cutting the implant with the cable cutter, article number 391.905.Because of the damage the complaint relevant dimensions cannot be checked to specifications anymore.The dhr review shows that the production procedure was according to the specifications at the manufacturing time in july 2016 and there were no issues that would contribute to this complaint condition.No manufacturing 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 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: 6739760
• MDR Text Key: 80947725
• Report Number: 9612488-2017-10319
• 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
• Report Date: 06/27/2017

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: L035723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INSTRUMENT (PART # UNKNOWN, LOT # UNKNOWN, QTY 1)