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 Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2018, the patient underwent a redo mitral valve replacement.During the procedure the zipfix application instrument would not tighten and the surgical team obtained another zipfix application device on the shelf.No surgical delay was reported and the procedure was completed successfully.No complications to the patient were reported.This report is for an 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.A device history record review was performed for the subject device: part no.: 03.501.080 , lot no.: l619784 , manufacturing location: haegendorf , release to warehouse date: 13.Oct.2017.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.No nonconformances (ncrs) were generated during production.A product development investigation was performed for the subject device: it was reported that on (b)(6) 2018, the patient underwent a redo mitral valve replacement.During the procedure the zipfix application instrument would not tighten and the surgical team obtained another zipfix application device on the shelf.No surgical delay reported and the procedure was completed successfully.No complications to the patient reported.Service & repair evaluation: the customer reported the zipfix gun would not tighten.The repair technician reported the spring on the front of the instrument was damaged and not allowing the device to function.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.Customer quality evaluation: the instrument was received with the reported condition of ¿will not tension/tighten : rm¿ at customer quality, the returned instrument was inspected and the complaint was confirmed.The following investigation flow was performed: damage: visual (appearance not as expected): the returned instrument was examined and the complaint condition was able to be confirmed as the as the front spring is damaged which may prevent the device from functioning as intended.The reported complaint condition was able to be replicated.The received condition agrees with the complaint description.A device history review was performed for the returned instrument¿s lot number and no ncrs, mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Also, based on the device history record review, there is no indication that any issues with material or material properties contributed to the complaint condition.Relevant drawings for the returned device were reviewed: top-level drawing for application instrument for sternal zipfix 03.501.080 and determined to be suitable for the intended design and application when used as recommended.A dimensional inspection of features related to this complaint could not be performed at cq because the feature(s) of interest are internal to the assembled condition of the device and would be damaged in attempt to access them.While no definitive root cause could be determined it is possible that any excessive unintended forces encountered by the device during usage or handling could have contributed to the complaint condition of this reusable instrument.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.

Event Description

It was reported that on (b)(6) 2018, the patient underwent a redo mitral valve replacement.During the procedure the zipfix application instrument would not tighten and the surgical team obtained another zipfix application device on the shelf.No surgical delay reported and the procedure was completed successfully.No complications to the patient reported.Patient was discharged on (b)(6) 2018.Concomitant device reported: unknown zipfix implant (part # unknown, lot # unknown, quantity 1).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.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: 7534433
• MDR Text Key: 109000834
• Report Number: 2939274-2018-52263
• 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: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• 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: L619784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR