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

Model Number 03.501.080

Device Problems Device Difficult to Maintain (3134); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device returned.Occupation: j&j rep.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Field stocking location.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 unknown date, the application instrument for sternal zipfix gun hasn¿t been working correctly, the note from the account says ¿catching and not tightening correctly." the sales consultant plugged it in and it didn¿t work anymore.It¿s just not working.No case impacts and no patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Event Description

On (b)(6) 2019: updated event description: it was reported that on unknown date, the application instrument for sternal zipfix gun hasn¿t been working correctly, the note from the account says ¿catching and not tightening correctly¿.The sales consultant plugged it in and it didn't work anymore.The zipfix gun was not used on a patient.It jammed post case during processing.No case impacts and no patient involvement.This complaint involves one (1) device.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b5: updated event description provided for reporting.D4: lot number provided e1: reporter's information h3, h4, h6: a review of the device history record has been requested.H11: b6/b7 d4: lot number provided h3 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

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Service & repair evaluation: the customer reported the application instrument for sternal zipfix gun hasn¿t been working correctly, the note from the account says ¿catching and not tightening correctly¿.The repair technician reported the device failed during check handle screws.Loose component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: gen 2 handle screws.The item was repaired per the inspection sheet, passed synthes final inspection on 27-aug-2019 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 40.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.  h3, h4, h6: a device history record (dhr) review was conducted: product code: 03.501.080.Lot number: l755312.Release to wareouse: 15-feb-2018.A manufacturing record evaluation was performed for the finished device l755312 number, and no non-conformances were identified.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this 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.

• 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
• MDR Report Key: 8885643
• MDR Text Key: 154544754
• Report Number: 2939274-2019-59718
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(
• Combination Product (y/n): N
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• 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: L755312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 09/13/2019
• Patient Sequence Number: 1