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

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, due to a mismatch of an expert a2fn nail and the zig(insert-handle for a2fn), there was difficulty for an unknown hip screw to pass through the nail.The issue occurred during fracture fixation surgery for subtrochanteric fracture.The procedure was successfully completed by removing the nail.A new nail was inserted and it was discovered that the previous nail was damaged because of improper alignment of zig and nail.There was a sixty (60) minute surgical delay.Patient status is stable.This report is for one (1) - nail head elements: hip screw.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Updated event description provided for reporting.Investigation summary complained issue could not be replicated and/or confirmed based on the available information.No pictures and/or x-ray¿s were provided and no material was returned for investigation.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 (information or/and material), 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 Description

(b)(6) 2019: updated event description: it was reported that on (b)(6), 2019, due to a mismatch of an expert a2fn nail and the zig(insert-handle for a2fn), there was difficulty for an unknown hip screw to pass through the nail during fracture fixation procedure for subtrochanteric fracture.The nail was removed and a new nail was inserted as the previous nail got damaged because of improper alignment of zig and nail.The procedure was successfully completed.There was a 60 minutes surgical delay.Patient status is stable.This complaint involves three (3) devices.

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.H10 additional narrative: a3.Patient details: sex/gender - male provided for reporting.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.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8390157
• MDR Text Key: 137830380
• Report Number: 8030965-2019-61733
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2019
• Patient Sequence Number: 1