MAUDE Adverse Event Report: SYNTHES HAGENDORF APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Catalog Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product or any subcomponents that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.A service and repair evaluation was performed for the subject device.The customer reported the item was not tightening properly.The repair technician reported the screws were loose.¿loose component¿ is the reason for repair.The cause of the issue is unknown.The following parts were replaced: gen 1 handle screws a (7), gen 1 handle screws b (7).The item was repaired per the inspection sheet, passed synthes final inspection on 22-jun-2016 and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived in docusphere document management system.The evaluation was confirmed.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 while attempting to tighten zipfix implants during a procedure on an unknown date, the surgeon could not get the application instrument to tighten properly.A backup application instrument was used to complete the procedure.There was no surgical delay reported and no adverse impact to the patient.This is report 1 of 1 for (b)(4).

• Brand Name: APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5765459
• MDR Text Key: 48668131
• Report Number: 3003875359-2016-10398
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/16/2016

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 Catalogue Number: 03.501.080
• Device Lot Number: 7606881
• Other Device ID Number: (01)10887587010847(10)7606881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0276-2016
• Patient Sequence Number: 1