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

Device report from synthes (b)(4) reported an event in (b)(6) as follows: it was reported that the application instrument trigger jams.When releasing the trigger the actuator feels something like a punch/ hit because of the jamming.The reported issue was detected before surgery.No patient was involved and the failure was detected before surgery.A substitute instrument was used for the surgery.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 13.Jan.2014, 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.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

The original date of awareness was inadvertently missing from the initial medwatch.April 7, 2015 has been populated in this field.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.

Manufacturer Narrative

A product evaluation was performed, after the instrument was lubricated as per the manufacturer¿s instructions, the function of the instrument was fully restored and three implants could be tensioned and cut as per the design intent.A result of any design related deficiency the present article was analyzed for conformance to print specifications as well as the device history record was researched; no abnormal findings were identified.Manufacturing and inspection records indicated no problems with the lot in question.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.The complained instrument has been forwarded to the product development site and we are now in the receipt of the investigation results; in this non-manufacturing complaint investigation it was found that the trigger of the instrument, as per the complaint description, did not always function freely.However, after the instrument was lubricated as per the manufacturer¿s instructions, the function of the instrument was fully restored and three implants could be tensioned and cut as per the design intent.The cause of the functional issue is related to the not preformed lubrication of the device by the user.No design related issues could be identified by product development.As no product fault could be detected, no further action is required.Dhr review no findings, chu evaluation, and visual check no findings; the trigger did not always function freely.After lubricate the instrument/trigger is fully functionally, pd evaluation, no findings.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: 4718709
• MDR Text Key: 5585318
• Report Number: 3003875359-2015-10179
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/07/2015

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: 8789316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2015
• Initial Date FDA Received: 04/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/11/2015; 06/23/2015; 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2014
• 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