MAUDE Adverse Event Report: SYNTHES SALZBURG 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/255MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.019.255S

Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported during the surgery, the surgeon decided to replace the just implanted nail by a longer nail, because the first nail was too short.During the removal of the nail the thread has turned up spirally.No delays or patient harm were reported.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.No nonconformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: manufacturing evaluation: our investigation has shown that the nail interface is indeed badly damaged.We do suppose that far too much mechanical force or an inappropriate connection between the nail and the insertion handle may have caused this damage.There is the possibility that the insertion handle might be damaged, unfortunately it has not been returned for inspection.The article was analyzed for conformance to print specification, as well as the device history record was researched.No abnormal findings were identified.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: 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/255MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer (Section G): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4361559
• MDR Text Key: 15894193
• Report Number: 3009417901-2014-10034
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: 04.019.255S
• Device Lot Number: 5928407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1