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 Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales consultant the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 two (2) zipfix application tools were found to be inoperative during preoperative inspection.These devices are damaged and don¿t latch as they should.The cutting levers did not fully engage in the locked position preventing the tensioner to activate.There was no patient involvement.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Corrected data: manufacturer name, city and state.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 device history record (dhr) review was performed for part # 03.501.080, lot # 9742689 : manufacturing location: (b)(4), release to warehouse date: 03.Dec.2015: no non-conformance reports (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.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 device history record (dhr) review was performed for part # 03.501.080, lot # 9752689 : manufacturing location: (b)(4), release to warehouse date: 03.Dec.2015: no non-conformance reports (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 and repair evaluation: the customer reported the device was damaged and would not latch, and the cutting lever would not activate.The repair technician reported the cutting lever tab was bent, and the trigger was sticking.Bent 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.Service history review: no service history review can be performed as part number 03.501.080 with lot number(s) 9742689 is a lot/batch controlled item.The service history review is unconfirmed.The device was returned to customer quality.The report that the cutting lever would not activate was replicated during investigation.The complaint was confirmed.The cutting lever tab was found to be bent, and is preventing the other device components from functioning as intended.Dimensional inspection was not able to be performed on the assembled device.Relevant drawings were reviewed during investigation.Review of the device history record(s) showed that there were no issues during the manufacture of the product including material, 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.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): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7084293
• MDR Text Key: 94233907
• Report Number: 8030965-2017-50327
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(10)9742689
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/06/2017

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: 9742689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 12/07/2017; 01/03/2018; 01/04/2018
• Supplement Dates FDA Received: 01/02/2018; 01/03/2018; 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• 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