MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH FEMORAL NECK SYSTEM INSERTION HANDLE; APPLIANCE, FIXATION, NAIL

Catalog Number	03.168.008
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent surgery involving a plate, a bolt and an insert for insertion handle.When the surgeon connected the insert to the insertion handle, the black screw of the insert was too tight to turn with his hands.The surgeon turned the black screw with a kocher forceps.After the surgery, the surgeon confirmed that the black screw can be turned smoothly.The surgeon commented that the bolt for construct length 70mm is needed.During the surgery, when the surgeon determined length, he read 72mm.Because the surgeon didn't have the bolt for construct length 70mm, he used the bolt for construct length 75mm instead.Patient status was stable.Concomitant devices: femoral neck system (fns) plate (part: 04.168.000s, lot: 4l16980, quantity: 1), fns antirotation screw (part: 04.168.475s, lot: 04.168.475s, quantity: 1), fns locking screw (part: 412.217s, lot: 2l78963, quantity: 1).This report is for a femoral neck system insertion handle.This is report 2 of 3 for (b)(4).

• Brand Name: FEMORAL NECK SYSTEM INSERTION HANDLE
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8910484
• Report Number: 8030965-2019-67507
• Device Sequence Number: 617646
• Product Code: KTT
• UDI-Device Identifier: 07611819657342
• UDI-Public: (01)07611819657342
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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: 03.168.008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1