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

Catalog Number 03.501.080

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Exact date of surgery, during which the malfunction occurred, is unknown.Device is an instrument and is not implanted or explanted.Service & repair evaluation: the customer reported the item was not crimping or tensioning properly.The repair technician reported loose component as the reason for repair.The cause of the issue is unknown.No parts were replaced.The item was repaired per the inspection sheet, then passed synthes final inspection on may 26, 2016.The device will be returned to the customer upon completion of the service and repair process.The device was officially manufactured on november 27, 2013, but was not released to the warehouse until december 4, 2013.Device history record review: manufacturing location: (b)(4) - manufacturing date: november 27, 2013.No anomalies were detected during device history record (dhr) review.No non-conformance reports were generated during production.Review of the dhr showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Service history record review: no service history review can be performed as part number 03.501.080 with lot numbers 8725323 is a lot/batch controlled item.The release to warehouse date of this item was december 4, 2013.The service history review is unconfirmed.Device 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 an application instrument for sternal zipfix would not crimp/tension properly during a surgical procedure on an unknown date.An alternate device was available for use to complete the procedure, which was done so without surgical delay or patient harm.This report is 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: 5685700
• MDR Text Key: 46114061
• Report Number: 3003875359-2016-10326
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2016

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: 8725323
• Other Device ID Number: (01)10887587010847(10)8725323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2013
• 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