MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L; APPLIANCE,FIXATION,NAIL

Model Number	04.168.495S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.(b)(4).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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent a surgery for the femoral neck fracture with femoral neck system (fns) and the locking screw.On (b)(6) 2019 the patient started partial weight bearing and from (b)(6) 2019 patient started full weight bearing.On (b)(6) 2019 the hospital confirmed the displacement at the fracture site and considered biarticular hip prosthesis surgery.On (b)(6) 2019 the patient underwent the removal of fns and biarticular hip prosthesis surgery.During the removal of fns, the surgeon could not remove the distal locking screw.The surgeon removed the screw with a carbide drill and removal instruments.The surgery was delayed by less than thirty (30) minutes.No further information is available.This report captures the post op event for displacement at the fracture site and considered biarticular hip prosthesis surgery while related complaint (b)(4) captures the intraoperative event for removal of fns and biarticular hip prosthesis surgery.This report is for one (1) anti-rotation screw for femoral neck sys 95 mm length - sterile.This is report 3 of 4 for complaint (b)(4).
Additional 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.H3, h4, h6: 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.
Additional 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.B3: date of event is an unknown date in 2019.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.

• Brand Name: ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8902612
• Report Number: 8030965-2019-67397
• Device Sequence Number: 2128200
• Product Code: KTT
• UDI-Device Identifier: 10886982274618
• UDI-Public: (01)10886982274618
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.168.495S
• Device Catalogue Number: 04.168.495S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 10/08/2019; 10/10/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 10/09/2019; 10/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 49