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

Model Number 03.501.080

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an unknown date, the application instrument, for sternal zipfix was discovered to be faulty during normal maintenance of the item.It does not appear to fully engage the tightening portion of the instrument.There was no patient and procedure involvement.This report is for one (1) application instrument for sternal zipfix.This is report 1 of 1 for complaint (b)(4).

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.A device history record (dhr) review was conducted: device history record (dhr) review for part#03.501.080 lot#7740498.Manufacturing location: synthes hagendorf.Released to warehouse date: 26jan2012.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.Record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was conducted.Service and repair evaluation: the customer reported the he application instrument, for sternal zippix was discovered to be faulty during normal maintenance of the item.The repair technician reported the device was missing 2 handle screws and center piece to hold the screws in.Missing parts 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.Flow: visual (appearance not as expected).Visual inspection: upon visual inspection it can be seen that the device is missing the following: 2 handle screws, a post to hold them in place, spring, end cap, and both spring stops.The device overall shows surface wear consistent with use.The received condition does agree with the complaint description as the missing components let to complaint condition.Document/specification review: the relevant drawing(s) was reviewed:no design or manufacturing defect or deficiency was observed during the investigation.From the drawings in can be seen that the 2 handle screws, a post to hold them in place, spring, end cap, and both spring stops and is needed for the device to function as intended and therefore a conclusive determination has been reached.A device history review, was performed for the returned instrument¿s lot number, no ncrs and no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Investigation conclusion: a definitive root cause for the given complaint condition could not be determined from the provided information.However, it is likely that the complaint condition occurred due to incorrect handling at the cleaning process or on a previous surgery.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 8205699
• MDR Text Key: 131801379
• Report Number: 2939274-2018-55635
• 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
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• 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: 7740498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1