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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 19.Nov.2012.No ncrs were generated during production.Review of the device history record(s) showed complaint condition 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 on an event in (b)(6) as follows: it was reported that the handle of the tension mechanism is sluggish.It happened during surgery.No delay to surgery.No patient harm.This complaint involves one part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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

Product development (pd) investigation: per the pd review, it was determined that this device was a second generation design.There was no evidence of wear visible on the returned device.Further, no design-related root cause was identified for the returned instrument.Rather, the root cause was likely due to insufficient lubrication during the reprocessing cycles.Product investigation summary: the returned instrument was functionally compared to a test instrument for handling as per the surgical technique guide.The returned instrument was less smooth in its tensioning function, which was likely due to insufficient lubrication of the instrument.As a result, the zipfix implants could not be tensioned as tight as intended.The cutting of the implants is as per the design intent with both instruments.The same functional comparison was done after lubricating the returned instrument.It was then observed that the returned instrument could achieve the intended tension of the implant around the sternum bone model.The returned instrument was found to be incorrectly reprocessed (insufficiently or not lubricated), which led to the malfunction encountered in the operating room.No indication for product related issues was found.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.

• 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: 5775069
• MDR Text Key: 48962530
• Report Number: 3003875359-2016-10401
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2016

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: 8159385
• Other Device ID Number: (01)10887587010847(10)8159385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/02/2016; 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2012
• 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