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

Catalog Number 03.501.080

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported during routine maintenance check, a zip fix instrument application instrument was found broken and the trigger is sticking on the gun.There was no patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.No patient involvement event date: unknown.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Dhr review ¿ 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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.

Manufacturer Narrative

A product evaluation was performed.The investigation of the complaint articles indicates that the:in this non-manufacturing complaint investigation the visual inspection and design evaluation were performed in the time of june 25-30, 2015 on the application instrument with the lot number: no damages or functional issues were identified.The performed handling test by product development on the returned instrument with 3 implants on a sternum bone model showed no functional deficiencies in tensioning and/or cutting the implants with the instrument.The tension applied is as per the design intent.Conclusion: there is no functional or design related issues identified on the returned instrument.This complaint is closed by product development as invalid.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): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4835092
• MDR Text Key: 5908849
• Report Number: 3003875359-2015-10262
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2015

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: 8725319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/13/2015; 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2013
• 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