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

Catalog Number 03.501.080

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(6).The visual inspection of the returned device performed as part of the product investigation reported the second generation instrument shows little marks and scratches on some of the moving parts which would indicate a short time use of the device.No screws are loose or other damages are identified.The second generation instrument was inspected and an application test were three implants were tensioned and cut as per the design intent.The complaint description that the instrument trigger would get stack - when pulled all the way - could not be replicated with the returned device.However it was found that the instrument had not been lubricated as per the instructions provided by the manufacturer.This may have caused the functional issue in the operating room.There was no design related issues found on the returned instrument.The instrument in this complaint was not lubricated as per the instructions.The root cause is most likely related to the missing lubrication during the clinical reprocessing.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) reports an event in (b)(6) as follows: it was reported that during a sternal closure, the zipfix application instruments in two zipfix sets were sticking upon full squeeze of the instrument to tension the zipfix implants.The surgeons were able to complete the surgery with the devices, but did not like the way the instruments were sticking.No further information was provided.No patient or procedure harm noted.This is report number 1 of 2 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.A device history review was conducted.The report indicates that no ncrs were generated during production.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.

• 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: 4172355
• MDR Text Key: 12565522
• Report Number: 3003875359-2014-10323
• 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
• Report Date: 09/18/2014

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: 8488752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 10/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2013
• 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