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

Catalog Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the tensioning of zipfix applicator does not work properly.The failure was detected during inspection in technique department.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: event date: unknown.Device is an instrument and is not implanted/explanted.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 14.June 2013, review of the device history record showed that no ncrs were generated during production.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

Additional narrative: a product evaluation was performed.The investigation of the complaint articles indicates that: in this non-manufacturing complaint investigation the visual inspection and design evaluation were performed on july 07, 2015 on the returned application instruments with the lot number: 8476268.No damages or functional issues were identified.The performed handling test by product development with the 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.This complaint is closed by product development as invalid.An investigation summary was performed.The investigation of the complaint articles has shown that: 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; no damages or functional issues were identified.The performed handling test by product development with the 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.As no product fault could be detected, no further action required.There is no functional or design related issues identified on the returned instrument.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.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: 4803547
• MDR Text Key: 5832820
• Report Number: 3003875359-2015-10235
• 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
• Report Date: 05/06/2015

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: 8476268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/26/2015; 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2013
• 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