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

Catalog Number 03.501.080

Device Problems Break (1069); Component Missing (2306)

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

Event Type  malfunction  

Event Description

It was reported that when the nurse opened up the zipfix container a screw was noted to be loose from the gun.The screw was found in the pan.This occured with the patient in the room.The nurse had another readily available, there was no impact to the patient.(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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 that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.A product development investigation was also performed for the subject device.The subject device is a ¿first generation¿ instrument and was received with marks showing long-time usage.Except for the loose ¿nut¿ component and spring, which was returned with this complaint, no other damages or loose screws are identified.In this non-manufacturing complaint investigation the visual inspection and design evaluation it was determined that the ¿nut¿ component of the instrument, which holds the tension limiting spring in place, had become loose and unthreaded from the instrument.The loosening of the ¿nut¿ component was addressed in (b)(4) 2013 by the manufacturing site.By providing instructions for the assembly line to use an approved ¿thread glue¿ to secure the nut.The complaint condition was confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 PA 19380 CH4; SZ 19380 CH46
• 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: 4632570
• MDR Text Key: 5614743
• Report Number: 2520274-2015-12125
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2015

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: 8068078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 03/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/03/2015; 06/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2012
• 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