MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE; APPLIANCE,FIXATION,NAIL

Catalog Number 04.168.000

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.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 Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent a removal surgery for femoral neck system due to an implant cut out.An x-ray was taken on unknown date and showed an unlocked antirotation screw.Removal of the femoral neck system was very difficult thus the surgeon needed to use an unknown operance instrument kit during removal.The surgery took an hour and thirty (30) minutes to complete.Patient and procedure outcome are unknown.This (b)(4) captures the intra-operative event occurred during removal surgery.(b)(4) captures post-operative event that required removal surgery.Concomitant devices: locking screw (part unknown, lot unknown, quantity 1).This report is for one (1) femoral neck system plate.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The initial complaint was reviewed and found not reportable.It was determined the parts should be captured as the implant kit.This report is now being captured under medwatch report 8030965-2018-59280.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 Description

The initial complaint was reviewed and found not reportable.It was determined the parts should be captured as the implant kit.This report is now being captured under medwatch report 8030965-2018-59280.

• Brand Name: FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8186374
• MDR Text Key: 131144402
• Report Number: 8030965-2018-59202
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334089687
• UDI-Public: (01)07612334089687
• Combination Product (y/n): N
• PMA/PMN Number: K172872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.168.000
• Device Lot Number: L468773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 12/27/2018
• Supplement Dates FDA Received: 12/27/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention