MAUDE Adverse Event Report: SYNTHES HAGENDORF INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX; GUIDE

Catalog Number	03.008.007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement.Date of device breakage is not known.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: 17.Dec.2009.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.
Event or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported upon receipt of a loaner set from the distributor it was noted the insertion handle for hindfoot arthrodesis nail-ex had one tooth broken off and another is bent and deformed.No patient involvement.This report is for one (1) insertion handle for hindfoot arthrodesis nail-ex this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The device has been received and the product evaluation is in progress.No conclusion can be drawn.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.
Additional Manufacturer Narrative
Product development investigation was completed.The report indicates that the: article 03.008.007 lot 3307772.The returned insertion handle shows a lot of heavy wear marks and scratches at the whole instrument.One of the two pins on top of the instrument is broken off, the second pin is partly broken off.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.Further investigation has shown that this instrument was manufactured in december 2009 and now more than 7 years old.Based on the provided information we are not able to determine the exact cause which has led to these damages.But based on the age of the instruments and the strongly visible wear marks and scratches, it is likely that a improper handling over the years has caused the damages.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: INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6755294
• Report Number: 3003875359-2017-10375
• Device Sequence Number: 10803728
• Product Code: FZX
• UDI-Device Identifier: 07611819868540
• UDI-Public: (01)07611819868540(10)3307772
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.008.007
• Device Lot Number: 3307772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 08/03/2017; 09/28/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 08/04/2017; 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1