MAUDE Adverse Event Report: SYNTHES BETTLACH STERNAL ZIPFIX WITH NEEDLE STERILE; CERCLAGE FIXATION

Catalog Number 08.501.001.01S

Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: although the product issue was discovered on (b)(6) 2016, it is unknown when the device ribbing portion (locking mechanism) was missing from the device.(b)(4).(b)(6).The subject device is expected to be returned to the synthes manufacturer for evaluation.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.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.

Event Description

Device report from synthes (b)(4) reported an event in (b)(6) as follows: it was reported that the locking mechanism of two zipfix implants did not work properly; the ribbing portion of the implant is missing.The issue was detected preoperatively on (b)(6) 2016 and there was no patient involvement.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device (sternal zipfix with needle sterile, part number 08.501.001.01s, lot number 9659492).The subject device was returned for the complaint that reported that the ribbing (tooth) at the sternal zipfix implant is missing.It was reported that the failure was detected preoperatively; however, visual inspection of the implant revealed ¿the implant is bent and has specific bending areas as they appear only when the implant is placed inside the patient to fixate the sternum.¿ the cut end of the received implant was twisted off.The twisting led to an increased cross-sectional area which does not fit through the locking head without causing damage to the locking feature.The locking feature teeth were clearly deformed and damaged.The current released surgical technique guide indicates a precaution which states: ¿removing the needle by bending or twisting will cause a deformed end that may damage the locking head during insertion.Always ensure that the implant end is cut and not deformed.If the implant is not cut, implant failure may occur.¿ based on the findings documented it is concluded that the device needle was incorrectly removed (twisted off) in the area of the bending feature by the user.This action increased the device cross sectional area as shown in picture 2 and while inserting the ¿device end¿ into the ¿locking head¿ the locking feature`s teeth were deformed, as well as the locking feature itself was pushed past its flexible state so that a device locking was compromised.No design related root cause has been identified on the returned device.The root cause of the returned device is user handling related.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: an investigation summary was performed.The investigation of the complaint articles has shown that: etq complaint description: ¿it was reported that the ribbing (tooth) at the sternal zipfix implant is missing.The failure was detected preoperatively, therefore no patient involvement.Ribbing at the sternal zipfix implant is missing.There two implants where the locking mechanism does not work properly.One of the zipfix implants be wasted by customer and would not returned.¿ according to the updated device report, both implants are from the same lot number and the cause of the returned device is user handling related.The second device reported in this complaint was not received and could not be reviewed within this investigation.No design related root cause has been identified on the returned device.The non-manufacturing, product development evaluation is closed as invalid.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: STERNAL ZIPFIX WITH NEEDLE STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5391649
• MDR Text Key: 36849816
• Report Number: 9612488-2016-10055
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 08.501.001.01S
• Device Lot Number: 9659492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1