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

Model Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing location: (b)(4).Manufacturing date: 10.Sept.2013.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 the application instrument for sternal zipfix does not feed the tape as it should.The band will tighten slightly but not enough to join the edges of the bone together.It is further reported there will be a loose loop of the band and the edges will not contact.Surgeon resolved the issue by pulling the band in advance using a regular forceps.No patient harm was reported.This report is for one (1) application instrument for sternal zipfix.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: date received.Hospital telephone: (b)(6).Title.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

A product development investigation was performed for the subject device (application instrument for sternal zipfix, part number 03.501.080, lot number 8572599).The returned instrument was compared in a functional test with the ¿test instrument¿ in regards to its handling, as per the technique guide steps 2 through 8 of the systems surgical technique guide.It was found that the returned instrument from this complaint is fully functional, as per the design intent.It is noted that the instrument was returned ¿not lubricated¿ despite the clinical reprocessing instructions.Based on the complaint description, the instruments was likely not been lubricated.No design related root cause has been identified on the returned instrument.The instrument functions as per the design intent.Therefore, the complaint is closed by sustaining engineering as invalid.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6762101
• MDR Text Key: 82159633
• Report Number: 3003875359-2017-10378
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(10)8572599
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2017

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 Model Number: 03.501.080
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8572599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/02/2017
• Supplement Dates Manufacturer Received: 08/03/2017; 08/23/2017
• Supplement Dates FDA Received: 08/04/2017; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2013
• 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
• Patient Age: 64 YR