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  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.No anomalies were detected during device history record review.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported that the cutting mechanism on an application instrument for sternal zipfix is not working properly.It is leaving a burr in the polyetheretherketone (peek) implant.This was discovered during an in-service; there was no patient or procedure involvement.(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date device was received by manufacturer for evaluation.The device is currently in the evaluation process.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.A product development investigation was performed for the complaint device (application instrument for sternal zipfix, part number 03.501.080, lot number 7666085).The device was received with the complaint ¿that the cutting mechanism on an application instrument for sternal zipfix is not working properly.It is leaving a burr in the polyetheretherketone (peek) implant.This was discovered during a servicing.No procedure involvement.¿ the customer quality investigation shows that this device is part of the sternal zipfix system and used to tension and cut the sternal zipfix implants.Proper use and maintenance is addressed in the sternal zipfix system technique guide.A review of the current design drawing and relevant design history was performed.The following component drawings were also reviewed; cutter assembly and cutter.During use the device is intended to cut sternal zipfix implants which are specified as peek optima lt3 per the drawing compared to the cutter which is hardened and tempered 1.4112 (type 440b) stainless steel, per a different drawing.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The design of the cutter and cutter assembly were determined to be suitable for the intended use when employed and maintained as recommended.As previously reported, the device history record review found the instrument to have been manufactured in (b)(4) on 29-nov-2011.No anomalies were detected during device history record review.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received intact with light scratch wear.Two small indents were observed on each of the two distal cutting edges.The device was functionally tested with an in-house demo implant (d000061) and it was noted that the edge of the cut surface was slightly rougher where it aligns with the indents on the cutting surfaces.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated.Review of the failure mode determined that the deformation of the cutting edges is the result of a force beyond the yield strength of the material and likely resulted in the improper cutting of the implant.Damage of this nature would not be expected when used as recommended.However, since it is unknown when and how the damage occurred, a root cause cannot be definitively determined.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 CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5815400
• MDR Text Key: 50414968
• Report Number: 3003875359-2016-10426
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2016

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: 7666085
• Other Device ID Number: (01)10887587010847(10)7666085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/12/2016; 08/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2011
• 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