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

Catalog Number 03.501.080

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2015

Event Type  malfunction  

Event Description

It was reported that a zipfix gun is broken; the trigger "will not pull".This was noticed during routine inspection.No procedure or patient involvement reported.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.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

Synthes manufacturing location was discovered upon receipt of subject device.Manufacturing location: (b)(4), manufacturing date: 18 june 2013, no ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.An investigation summary was performed.The investigation of the complaint articles has shown that: one application instrument for sternal zipfix (part number 03.501.080, lot number 8419600) was received with the complaint that the trigger "will not pull." the complaint condition is confirmed as the trigger cannot be operated due to the bending of the spring stop components.This condition was reported to have been noticed during routine inspection; therefore, the specific circumstances at the time of the damage are unknown.Thus, the root cause could not be determined.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.However, the current risk assessment does not adequately address the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Thus, no additional actions are needed.The trigger cannot be operated due to the bending of the spring stop components, especially the left component.It would be expected that only high compressive force may have led to bending of the locking springs.This condition was reported to have been noticed during routine inspection; therefore, the specific circumstances at the time of the damage are unknown.Thus, the root cause could not be definitively determined.This investigation summary have been approved.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

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; 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 CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4884851
• MDR Text Key: 6262193
• Report Number: 2520274-2015-14740
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• PMA/PMN Number: PK110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Type of Report: Initial,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• 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: 8419600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2013
• 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