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 Date 04/05/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.(b)(6).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 subject device has been received and 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.

Event Description

Device report from synthes (b)(4) reported an event in (b)(6) as follows: it was reported that the applicator instrument sternal zip fix failed to tighten the implant during closure.There was a 10 minute surgical delay due to the reported event.The surgery was successfully completed without additional intervention.The patient's post-operative condition was reportedly fine.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product development evaluation: a single application instrument (lot 9742168) was received for this non-manufacturing evaluation.No damages or deformations could be found on the returned device.During the functional check, it was noticed that the instrument had not been lubricated per the clinical reprocessing instructions provided by the manufacturer.This likely had an influence of the general handling of the instrument.The attempt to tension the first of five implants on a bone model confirmed a functional issue with the instrument.However, once the instrument was lubricated, the function was fully restored and the instrument worked per intent.It is therefore concluded that the reported malfunction of the instrument is related to the lack of lubrication during the clinical reprocessing cycle.No design related root cause is identified for the returned device.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: 5597507
• MDR Text Key: 43320904
• Report Number: 3003875359-2016-10253
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

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: 9742168
• Other Device ID Number: (01)07611819418424(10)9742168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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