MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Model Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review is pending completion.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 on (b)(6) 2017, patient underwent procedure for a coronary artery bypass graft.During the procedure, the application instrument ((b)(4)) for sternal zipfix would not tighten the zip fix as tight as the surgeon wanted.The application instrument appeared to be slipping while tightening the zip fix.Surgeon decided to use both zip fix implants and sternal wires (unknown competitor¿s devices).There was no surgical delay, the surgery was completed successfully with no additional medical intervention required and no delay.The patient was stable following surgery.Concomitant medical devices: zipfix implants (part number unknown, lot number unknown quantity 4).This report is for one (1) application for instrument for sternal zipfix.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Patient height reported as 5¿9¿.Returned to manufacturer.Dhr review: part no.: 03.501.080, lot no.: 9815030, manufacturing location: (b)(4), release to warehouse date: 12.Feb.2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Service history review: the customer reported the zipfix gun would not tighten.The repair technician reported the cutter was broken, and the trigger was sticking.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Investigation summary: the device was initially returned to service and repairs where it was determined to be not repairable and forwarded to customer quality.The returned instrument (part 03.501.080, lot 9815030, mfg 12.Feb.2016) was inspected at customer quality and the complaint was confirmed.The instrument was returned broken.Whether this complaint could be replicated is not applicable because the device was returned broken.Investigation methods/ evaluation results: a visual inspection, drawing and device history record review were performed as part of this investigation.Dimensional analysis is not applicable at this time as relevant features were not returned.Material and hardness testing is not applicable at this time as they were tested at the time of manufactured and confirmed to have no issues through the dhr review.Upon visual inspection, it was noted that the cutter was broken and the fragment was not returned.Additionally, the and the trigger was stiffer than normal.Drawing (current and mfg) were reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition therefor no further corrective and preventive actions are proposed.Corrected data: legal 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.

• Brand Name: APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7071980
• MDR Text Key: 94199729
• Report Number: 8030965-2017-50187
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(10)9815030
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

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 Model Number: 03.501.080
• Device Catalogue Number: 03.501.080
• Device Lot Number: 9815030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 12/28/2017
• Date Device Manufactured: 02/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 82