MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HYBRID INSERTION HANDLE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.011

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, a patient underwent an unknown procedure using a trochanteric femoral nail-advanced system (tfna) for an unknown reason.During the procedure, when the tfna nail was about to detach after insertion, the nail got stuck on an insertion handle along with the connecting screw.Thus, the surgeon replaced a new nail with other insertion handle but still, the nail got stuck from the handle.It was unknown if there was a surgical delay reported and if there was an adverse event to the patient.Procedure outcome was unknown.This complaint involves (3) devices.This report is for (1) hybrid insertion handle.This report is 1 of 3 for (b)(4).

• Brand Name: HYBRID INSERTION HANDLE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8262498
• MDR Text Key: 133834768
• Report Number: 8030965-2019-60085
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• 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
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1