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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no patient involvement.Date of event: it is unknown when device began to malfunction.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history records review has been requested.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 during routine maintenance of the instruments on (b)(6) 2018, the sales consultant noticed that three (3) hand piece for battery powdered driver and the application instrument for sternal zipfix had a malfunction issue.It was noted that two of the hand pieces were not working and the third did not turn.It was also reported that the application instrument for sternal zipfix did not grab or tighten on an unknown sternal zipfix implant.There was no patient involvement.Concomitant devices: sternal zipfix implant (part: unknown, lot: unknown, quantity: 1).This report is for a application instrument for sternal zipfix.This is report 1 of 1 for (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.Part: 03.501.08; lot: 8735246; manufacturing location: haegendorf; release to warehouse date: december 05, 2013; no nonconformance 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 & repair evaluation the customer reported the zipfix gun would not grab or tighten.The repair technician reported the retaining nut and two of the handle screws were loose.Loose component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: gen 2 handle screws (2).The item was repaired per the inspection sheet, passed synthes final inspection on june 15, 2018 and will be returned to the customer upon completion of the service and repair process.Service record router completed through operation 40.Finalized service record will be archived in document management system.The evaluation was confirmed.Service & repair history no service history review can be performed as part number 03.501.080 with lot number(s) 8735246 is a lot/batch controlled item.The service history review is unconfirmed.The device was deemed serviceable and 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.Conclusion codes: operational context caused or contributed to event.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: 7605318
• MDR Text Key: 111178063
• Report Number: 2939274-2018-52510
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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: 8735246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1